On February 11, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) reported that the first patient has been enrolled in a clinical study evaluating Lymphoseek (technetium Tc 99m tilmanocept) injection in women with known cervical cancer (Press release, Navidea Biopharmaceuticals, FEB 11, 2016, View Source;p=RssLanding&cat=news&id=2137497 [SID:1234509037]). The study, funded by a Fast-track grant from the National Institutes of Health (NIH), National Cancer Institute (NCI; 1R44CA180390-01) will assess the use of Lymphoseek in sentinel lymph node biopsy (SLNB) during cervical cancer surgery in support of the existing Lymphoseek label in lymphatic mapping. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Enrollment is currently planned in up to six sites throughout the U.S. The first patient has been enrolled by the principal investigator, Michael M. Frumovitz, M.D., M.P.H., Associate Professor, Department of Gynecologic Oncology and Reproductive Medicine, at The University of Texas MD Anderson Cancer Center.

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"This important study could potentially advance the use of SLNB procedures in cervical cancer. Clinical experience and published results using Lymphoseek in other cancer types demonstrate that imaging using Lymphoseek may enable detection of suspicious nodes not previously possible," said Frederick Cope, Ph.D., M.S., F.A.C.N., C.N.S., Senior Vice President and Chief Scientific Officer of Navidea. "Improving current practice in lymph node mapping and sentinel node detection in cervical cancer surgery may lead to less extensive, more focused surgical procedures. More reliable bilateral SLN identification may decrease the cost and morbidity of complete lymph node dissection in women with early stage cervical cancer."

"There is currently a growing focus on sentinel lymph node biopsy (SLNB) procedures in gynecologic cancers. Lymphoseek has been safely and efficaciously used in SLNB and mapping procedures in over 50,000 patients to date," said Rick Gonzalez, President and Chief Executive Officer of Navidea. "With Lymphoseek’s immunodiagnostic properties of selective receptor targeting and improved patient experience, we believe that this study and others like it may accelerate the adoption of lymphatic mapping and SLNB using Lymphoseek in cervical cancer and other solid tumor areas with the intent of improving patient outcomes and reducing post-surgical morbidities in patients undergoing these procedures."

This multi-center, prospective, open-label study is designed to evaluate Lymphoseek in patients with known cancer of the cervix. The trial intends to enroll up to 40 women with International Federation of Gynecology and Obstetrics (FIGO) IA2-IIA1 staging. Subjects will receive a single dose of Tc99m tilmanocept administered peritumorally approximately 1-2 hours before surgery. The results will report per-patient false negative rates and compare the pathology status of Lymphoseek-identified sentinel lymph nodes relative to the pathology status of non-sentinel lymph nodes in nodal staging of patients. Additionally, the study will report sensitivity, negative predictive value, and accuracy. Concordance and reverse concordance of identified nodes will be reported for the cases that use both Lymphoseek and a dye. Information on the protocol for this study (NAV3-19) can be found at: View Source;rank=5.

About Cervical Cancer

Cervical cancer is usually a slow-growing cancer that affects ~12,000 new patients each year in the U.S. Worldwide, the World Health Organization notes that cervical cancer is both the fourth most common cause of cancer and the fourth most common cause of death from cancer in women. Globally in 2012, it was estimated that there were 528,000 new cases of cervical cancer, and 266,000 deaths.

About Sentinel Lymph Node Biopsy1

A sentinel lymph node is defined as the first lymph node to which cancer cells are most likely to spread from a primary tumor. Sometimes, there can be more than one sentinel lymph node. A sentinel lymph node biopsy (SLNB) is a procedure in which the sentinel lymph node is identified using an imaging agent such as Lymphoseek, removed, and examined to determine whether cancer cells are present. A negative SLNB result suggests that cancer has not developed the ability to spread to nearby lymph nodes or other organs. A positive SLNB result indicates that cancer is present in the sentinel lymph node and may be present in other nearby lymph nodes or organs. This information helps a doctor determine the stage of the cancer and develop an appropriate treatment plan. SLNB may also help some patients avoid more extensive lymph node surgery and post-surgical complications such as lymphedema, or tissue swelling. SLNB is most commonly used to help stage breast cancer, melanoma and head and neck cancers. SLNB is also being evaluated along with lymphatic mapping in other cancer types, including cervical, endometrial, anal, colorectal, gastric, esophageal, thyroid, and non-small cell lung cancer.

Source: 1National Cancer Institute. View Source; accessed February 10, 2016.

About Lymphoseek

Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as results guide therapy decisions and determine patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 600,000 new cases of breast cancer, 160,000 new cases of melanoma and 100,000 new cases of head and neck/oral cancer diagnosed annually.

Lymphoseek Indication and Important Safety Information

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers. In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

On February 11, 2016 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies reported corporate highlights and financial results for the fourth quarter and year ended December 31, 2015 (Press release, Genocea Biosciences, FEB 11, 2016, View Source [SID:1234509036]).

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"2015 was another year of important progress for our lead product candidate, GEN-003 for genital herpes, and our ATLASTM T cell target discovery platform. In October, we demonstrated significant and durable Phase 2 efficacy for GEN-003, potentially positioning it to become the cornerstone treatment for the millions of people who suffer from genital herpes infections. 2016 will also be a rich year for GEN-003 clinical milestones with 12-month durability data from the ongoing Phase 2 trial expected later this quarter, virologic and clinical efficacy data from a Phase 2b study expected in the middle and second half of 2016, respectively, and an end-of-Phase 2 meeting with the FDA anticipated in the fourth quarter," said Chip Clark, president and chief executive officer of Genocea. "We also announced the application of our ATLAS platform to immuno-oncology and have ongoing cancer vaccine collaborations with leading researchers at Dana-Farber Cancer Institute and Memorial Sloan Kettering Cancer Center. We believe that ATLAS is unique and differentiated in its ability to identify clinically relevant targets for cancer vaccines, potentially enabling better efficacy and better outcomes for patients. We anticipate announcing data from these collaborations in 2016 and hope to be in the clinic with a cancer vaccine in 2017. We are funded into the second half of 2017 and remain in a strong position strategically with full control over the rights to our assets."

2015 Business Highlights and 2016 Anticipated Milestones

GEN-003 – Immunotherapy for treatment of genital herpes in Phase 2 development. Greater than $1 billion potential revenue opportunity in U.S. alone

Reported positive results six months after dosing from ongoing Phase 2 dose optimization trial in October 2015
In October 2015, Genocea reported positive results from a planned interim analysis of data collected six months after dosing from its ongoing Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. At its best performing dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant, GEN-003 demonstrated a statistically significant 58 percent reduction from baseline in the viral shedding rate (p < 0.0001), the primary endpoint of the study and a measure of anti-viral activity. In a planned secondary analysis, the proportion of patients receiving GEN-003 who were lesion-free at six months after dosing ranged from approximately 30 to 50 percent, similar to results reported in clinical trials with oral antiviral therapies. In addition, the time to first recurrence after completion of dosing showed a range of 152 days to greater than 180 days among dose groups. GEN-003 also demonstrated sustained and statistically significant reductions from baseline in genital lesion rates in five of six dose groups ranging from 43 to 69 percent. The ongoing Phase 2 trial continues to show that GEN-003 is safe and well tolerated by patients, with no serious adverse events related to the vaccine.

Multiple anticipated 2016 clinical milestones for GEN-003

Phase 2 12-month durability data expected in the first quarter of 2016
Phase 2b virologic efficacy data expected in mid-2016
Phase 2b clinical efficacy data expected in second half of 2016
End-of-Phase 2 meeting with the U.S. Food and Drug Administration expected in 4Q 2016
Later in the first quarter of 2016, the Company expects to report 12-month durability data from the ongoing Phase 2 dose optimization trial. Positive results, if achieved, would represent an improvement to the already-attractive 6-month durability of effect which was confirmed in the fourth quarter of 2015. This data is also expected to provide guidance on the frequency of administration of maintenance therapy with GEN-003.

In the middle of 2016, Genocea expects to report virologic efficacy data from a recently-initiated Phase 2b study. Positive results, if achieved, would confirm the activity of GEN-003 manufactured at commercial scale and are an important step towards the FDA end-of Phase 2 meeting, which is expected in the fourth quarter of 2016.

In the second half of 2016, the Company expects to report clinical efficacy data from this Phase 2b study. This placebo-controlled data represents the first opportunity to measure GEN-003 manufactured at commercial scale against potential Phase 3 endpoints at 6-months after dosing.

The Company also expects to commence a planned Phase 2b antiviral combination study in the middle of 2016. Clinical efficacy data from this trial is expected in the first half of 2017. If GEN-003 is additive to the effect of chronic suppressive oral anti-viral therapy, this would further strengthen GEN-003’s value proposition to patients and physicians.

Cancer Vaccine Programs – Developed from Genocea’s ATLAS technology platform for better T cell target discovery

New collaboration with Memorial Sloan Kettering Cancer Center announced in November 2015 to identify cancer vaccine candidates
Results from Dana-Farber collaboration presented as late-breaker at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting in November 2015

Immunotherapy program initiated in 2015 targeting Epstein-Barr Virus
The Company’s ATLAS T cell antigen discovery platform makes no assumptions about which cancer antigens are meaningful and which are not. It instead takes a panoramic view of the actual T cell responses of human subjects to any possible T cell target in a cancer. When applied across large diverse populations against common tumor-associated antigens, ATLAS could discover better targets for inclusion in general cancer vaccines. When applied to an individual’s response to their own cancer neoantigens, ATLAS could enable better personalized cancer vaccines, either as standalone therapies or in combination with other immunotherapies like checkpoint inhibitors.

The core strength of ATLAS is that it does not use predictive algorithms to identify antigens. It discovers clinically relevant T cell antigens associated with protective responses from comprehensive cell-based assays of actual human T cell responses.In contrast to predictive approaches to vaccine antigen selection, Genocea believes that ATLAS has a number of critical benefits, including that it potentially can find antigens to which patients are actually responding, distinguish between clinically relevant and immuno-dominant responses, identify separately targets of CD4+ and CD8+ T cells and is not HLA-limited. Genocea believes better vaccine targets may enable more efficacious and safer cancer vaccines and also the stratification of patients who may be best-suited to respond to immuno-oncology therapy or therapy combinations.

Memorial Sloan Kettering Cancer Center Collaboration
In November 2015, Genocea announced a collaboration with Memorial Sloan Kettering Cancer Center to screen the T cell responses of melanoma and non-small cell lung cancer patients treated with checkpoint inhibitors (CPI) against the complete repertoire of patient-specific putative cancer neoantigens. The goals of the collaboration are to identify signatures of T cell response in cancer patients associated with response or non-response to CPI therapy and to discover new T cell cancer vaccine antigens. ATLAS will be used in conjunction with Memorial Sloan Kettering’s patient-specific cancer neoantigen sequences and blood samples from the same cancer patients.

Dana Farber Cancer Institute Collaboration
In November 2015, findings that support the potential of ATLAS to profile responses to immunotherapies for cancer were presented as a late-breaker at the SITC (Free SITC Whitepaper) 30th Anniversary Annual Meeting & Associated Programs. This retrospective analysis of 10 checkpoint inhibitor (CPI) treated patients’ T cell responses to 23 known tumor-associated antigens, analyzed the immune responses of both responders and non-responders to CPI therapy. ATLAS successfully identified the cancer antigens to which either (or both) CD4+ or CD8+ T cells became activated. Although this research was not powered to draw firm conclusions, the analysis of T cell responses in patients receiving CPI therapy revealed a pattern indicating a greater breadth of T cell activation for responders than non-responders. The study also revealed preliminary evidence that different characteristics of T cell responses emerge when comparing patients who respond and those who do not. Some T cell responses did not correspond with improved patient outcomes, and may be classified as "decoys," further validating the potential ability of ATLAS to distinguish clinically relevant targets of T cell responses. Genocea partnered with Darren Higgins, Ph.D., professor of microbiology and immunobiology at Harvard Medical School and F. Stephen Hodi, Jr., M.D., director of the Melanoma Center at Dana-Farber Cancer Institute, to conduct this pilot study. Genocea’s collaboration with Dana-Farber Cancer Institute is ongoing as Genocea continues to analyze more tumor and blood samples to characterize T cell response profiles.

Epstein-Barr Virus Program
In November 2015, Genocea commenced a new program focused on Epstein-Barr Virus (EBV). EBV infection causes infectious mononucleosis and has also been linked to cancers with high unmet needs such as post-transplant lymphoproliferative disease, non-Hodgkin’s lymphoma, nasopharyngeal carcinoma and gastric carcinoma. Genocea believes that the ATLAS platform is highly suited to the creation of a new immunotherapy for EBV given that T cell responses are understood to be crucial for protection against EBV. Furthermore, EBV is part of the herpesvirus family, in which Genocea has deep experience through its development of GEN-003.

Genocea expects to announce further data from its ongoing immuno-oncology collaborations in 2016 and hopes to commence clinical trials with a cancer vaccine in 2017. For EBV, Genocea expect to have completed its initial ATLAS screening studies and to have identified a number of antigen targets for further research and pre-clinical development this year.

GEN-004 – Vaccine for the prevention of infections by all serotypes of pneumococcus.

Reported top-line results from Phase 2a clinical trial in October 2015

Development suspended pending review of potential paths forward
In October 2015, Genocea reported that top-line results from a Phase 2a clinical trial for GEN-004 showed consistent reductions versus placebo in the pre-specified endpoints of the rate and density of colonization, but neither of the endpoints achieved statistical significance. GEN-004 was safe and well tolerated by patients. Genocea believes that the consistent apparent effect demonstrates the potential of the vaccine concept and that it is possible that future trials would require a change in some combination of dose, adjuvant or trial population to confirm any effect. Genocea has suspended development in GEN-004 pending further review of the data and expert consultation.

Fourth Quarter 2015 Financial Results

Cash Position: Cash, cash equivalents and investments as of December 31, 2015 were $106.4 compared to $112.5 million as of September 30, 2015. Genocea expects that these funds will be sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2017.

Research and Development (R&D) Expenses: R&D expenses for the quarter ended December 31, 2015 decreased $2.1 million, to $6.5 million, from the same period in 2014, reflecting lower clinical and manufacturing costs for GEN-003 and GEN-004 due to the timing of clinical trial-related activities, including the suspension of development of GEN-004. These lower costs were partially offset by higher personnel and lab-related costs related to Genocea’s cancer vaccine programs and preclinical pipeline.

General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2015 were $3.8 million, compared to $2.6 million for the same period in 2014. The increase reflects higher personnel costs and depreciation expense, both of which support Genocea’s expanding R&D operations.

Net Loss: Net loss was $10.3 million for the quarter ended December 31, 2015, compared to a net loss of $11.7 million for the same period in 2014.

Full Year 2015 Financial Results

Cash Position: Cash, cash equivalents and investments as of December 31, 2015 were $106.4 million, compared to $47.1 million as of December 31, 2014. The increase was due to two follow-on offerings completed during the year with aggregate net proceeds of approximately $95.2 million , along with additional net borrowings of $4.7 million from a debt amendment executed in the fourth quarter of 2015 offset by cash used in Genocea’s operations and for capital expenditures.

R&D Expenses: R&D expenses for the year ended December 31, 2015 were $28.0 million, compared to $23.7 million for the same period in 2014, reflecting higher personnel costs and lab related costs both of which supported the continued advancement of the Company’s clinical programs along with increasing investments in Genocea’s cancer vaccine programs and preclinical pipeline.

G&A Expenses: G&A expenses were $14.0 million for the year ended December 31, 2015, compared to $9.7 million for the same period in 2014, reflecting additional personnel costs and depreciation expense supporting overall Company growth.

Net Loss: Net loss was $42.5 million for the year ended December 31, 2015, compared to a net loss of $35.3 million for the same period in 2014.

On Febrauary 11, 2016 Incyte Corporation (Nasdaq: INCY) reported its decision to discontinue the Phase 3 study (JANUS 1) of ruxolitinib or placebo in combination with capecitabine for the second-line treatment of patients with advanced or metastatic pancreatic cancer (Press release, Incyte, FEB 11, 2016, View Source;p=RssLanding&cat=news&id=2137479 [SID:1234509040]).

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The decision to stop the study was made after a planned interim analysis of JANUS 1 demonstrated that ruxolitinib plus capecitabine did not show a sufficient level of efficacy to warrant continuation.

Following these results, and the previously announced interim analysis of the Phase 2 sub-study of ruxolitinib or placebo in combination with regorafinib in patients with metastatic colorectal cancer and high C-reactive protein (CRP), ongoing Incyte-sponsored trials of ruxolitinib in solid tumors will be discontinued, including the Phase 3 JANUS 2 study in pancreatic cancer, the Phase 2 sub-study in patients with metastatic colorectal cancer and low CRP and the Phase 2 studies in breast and lung cancer. Incyte’s dose finding study of INCB39110 (a selective JAK1 inhibitor) as first-line treatment for metastatic pancreatic cancer, will also be discontinued. Incyte will work with investigators to appropriately conclude these studies in a manner consistent with the best interest of each patient. Data from these studies will be analyzed and shared with the scientific community over the coming months.

Ongoing studies of ruxolitinib and selective JAK1 inhibitors in hematology indications will continue. Ongoing studies of selective JAK1 inhibition in solid tumor indications that are based on different hypotheses will also continue. These include a series of studies evaluating INCB39110 in combination with either pembrolizumab (anti-PD-1 antibody), epacadostat (Incyte’s IDO1 inhibitor), or INCB50465 (Incyte’s PI3Kδ inhibitor) to assess the therapeutic utility of JAK1 inhibition based on its effects on the tumor microenvironment. Additionally, the potential impact of JAK1 inhibition on improving the benefit of targeted therapies will be investigated via a Phase 1/2 study of INCB39110 plus osimertinib, AstraZeneca’s next generation EGFR inhibitor.

"The hypothesis to evaluate the therapeutic utility of JAK inhibition in patients with solid tumors and high levels of systemic inflammation was initially supported by a subgroup analysis of the randomized, double-blind Phase 2 RECAP study, which suggested a survival benefit in patients with high levels of CRP. As a result, we and the broader scientific community believed further study in pancreatic cancer and other solid tumors with evidence of systemic inflammation was warranted. Unfortunately, the larger studies did not confirm this hypothesis," said Rich Levy, M.D., Chief Drug Development Officer of Incyte. "Moving forward, we remain focused on our strategy to invest in innovation and in our broad development portfolio, as we seek to deliver new medicines to patients with cancer and other diseases."

About JANUS 1
JANUS 1 (INCB 18424-362) was a randomized, double-blind, Phase 3 study of ruxolitinib or placebo in combination with capecitabine in patients with advanced or metastatic pancreatic cancer who had failed or were intolerant of first-line chemotherapy.

The primary objective of the study was to evaluate and compare the overall survival of patients treated with ruxolitinib in combination with capecitabine versus capecitabine alone. Secondary objectives evaluated and compared the efficacy of the two treatment groups with respect to progression-free survival, overall tumor response and duration of response, as well as safety and tolerability.

About Ruxolitinib (Jakafi)
Ruxolitinib (Jakafi) is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.

Ruxolitinib is not approved anywhere in the world as treatment for metastatic pancreatic cancer.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States.
Full Prescribing Information, including a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.

On February 10, 2016 Mylan N.V. (NASDAQ, TASE: MYL), a leading global pharmaceutical company ("Mylan"), reported a recommended public offer to the shareholders of Meda Aktiebolag (publ.) ("Meda") to tender all their shares in Meda to Mylan (the "Offer") (Press release, Mylan, FEB 10, 2016, View Source [SID:1234514659]). The total Offer consideration consists of a combination of cash and Mylan ordinary shares ("Mylan Shares") with a value at announcement of SEK 165 per Meda share. The total value of the Offer for all Meda shares, including Meda net debt, is approximately SEK 83.6 billion or USD 9.9 billion, which represents a multiple of approximately 8.9x 2015 adjusted EBITDA with synergies.

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The combination of Mylan and Meda will create a diversified global pharmaceutical leader with an expansive portfolio of branded and generic medicines and a strong and growing portfolio of over-the-counter (OTC) products. The combined company will have a balanced global footprint with significant scale in key geographic markets, particularly the U.S. and Europe. The acquisition of Meda also provides Mylan with entry into a number of new and attractive emerging markets, including China, Southeast Asia, Russia, the Middle East and Mexico, complemented by Mylan’s presence in India, Brazil and Africa. Mylan and Meda have a highly complementary therapeutic presence, which will create a leading global player in respiratory / allergy, and achieve critical mass in dermatology and pain, offering greater opportunities for growth in these categories.

The Offer has been unanimously approved by Mylan’s board of directors and unanimously recommended by Meda’s board of directors. Meda’s two largest shareholders, representing in the aggregate approximately 30 percent of Meda’s outstanding shares, have undertaken to accept the Offer, subject to certain conditions. Meda’s shares are listed on Nasdaq Stockholm, Large Cap. The Offer is subject to the satisfaction of a number of customary conditions, including clearance from relevant competition authorities, and is expected to be completed by the end of the third quarter of 2016. The Offer is not subject to approval by Mylan shareholders and is not subject to any financing conditions.

Comments from Mylan
Mylan Executive Chairman, Robert Coury, commented, "Our acquisition of Meda will allow us to accelerate and deliver on the clear and compelling vision and strategy we have continuously communicated to our shareholders, and once again deliver a transaction that will create significant value. We believe Mylan is uniquely positioned in the global pharmaceutical space today, with very strong fundamentals and a long and successful track record of executing on all previous acquisitions and organic opportunities. We structured this transaction in a way that optimizes our balance sheet and still leaves us ample financial flexibility to continue to complement our business with additional attractive opportunities.

"Meda is a unique and strategic asset, with a high quality workforce, which will add to our powerful, diversified and sustainable global platform and provide exciting new opportunities for Mylan, its shareholders and all of our other stakeholders. I look forward to welcoming Meda’s talented workforce to Mylan upon closing, and also to welcoming our newest shareholders, including Stena and Fidim. On behalf of Mylan’s entire board of directors, we look forward to them becoming long-term shareholders in the success of our combined company."

Mylan CEO, Heather Bresch, commented, "This transaction builds on everything we have put in place around the world, including our recent acquisition of the Abbott non-U.S. developed markets specialty and branded generics business. Meda brings us greater scale, breadth and diversity across products, geographies and sales channels, and together we will have an even stronger global commercial infrastructure. We have been very clear about our commitment to enter the OTC space and continue our expansion in emerging markets and, with this transaction, we will have an approximately $1 billion OTC business at close and gain entry into new growth markets such as China, Southeast Asia, Russia and the Middle East. Meda and Mylan also have an extremely complementary therapeutic presence and we see exciting opportunities across a number of strategically important categories, particularly allergy/respiratory, given the strength of our combined portfolio, the multitude of exciting launches we will have in the coming years, and the commercial strength of our combined business. Importantly, this transaction is extremely financially compelling, providing significant accretion to Mylan’s earnings per share, the opportunity for substantial synergies and the further acceleration of our growth trajectory, with the transaction providing the opportunity to achieve $0.35-$0.40 accretion in 2017 and to accelerate achievement of our previously stated $6.00 adjusted diluted EPS target to 2017, versus 2018.[1]

"Given our long relationship and existing successful EpiPen partnership in Europe with Meda, we have come to know their business, people and culture extremely well, and we are confident that we will be able to quickly begin realizing the significant value we see from this combination and continue to enhance our leadership position in today’s highly competitive and rapidly evolving industry."
Comments from Meda, Stena Sessan Rederi AB and Fidim S.r.l.
"On behalf of the Meda Board, I am pleased to announce that we recommend to our shareholders to accept Mylan’s Offer. We believe that the Offer provides excellent value for Meda shareholders and we share a common vision with Mylan to create a leading pharma player. The transaction will provide critical mass across all commercial channels in Europe, create a leading U.S. specialty business and provide an exciting platform for growth in emerging markets," said Peter von Ehrenheim, member of the Board of Directors of Meda.
"Over the course of more than 10 years, I have been privileged to first be a part of, and more recently to lead, Meda. I believe that Meda is an exceptional organization that has continued to go from strength to strength and has a strong and well-defined growth profile going forward. The proposed transaction with Mylan is very compelling from a strategic standpoint and I believe Meda will be a strong partner for Mylan and will bring additional value to Mylan. The two businesses are highly complementary, and the combined business will benefit from strong therapeutic presence in respiratory/allergy, dermatology and pain and inflammation, as well as enhancing our mass in Europe and US presence," said Chief Executive Officer of Meda, Dr. Jörg-Thomas Dierks.
"Stena Sessan welcomes the Offer made by Mylan and believes the combined entity will benefit all shareholders, given the combined scale in an ever consolidating market. The combined entity will create a global leader which is a diversified player across specialty, generics and OTC with a strong growth profile. Stena looks forward to becoming a long-term shareholder of Mylan," said Martin Svalstedt, Chairman of Meda and CEO of Stena Sessan AB.
"Fidim S.r.l. is delighted to receive the Offer from Mylan. Having been the owner of Rottapharm and then the second largest shareholder in Meda, we see this as the next step in continuing the market consolidation to extract the best value for all Meda stakeholders and to create a global pharma player of which we have the intention to remain a long-term shareholder," said Luca Rovati from Fidim S.r.l.
The Offer in brief
At announcement, the Offer consideration values each Meda share at SEK 165 and the total equity value of the Offer for all Meda shares is approximately SEK 60.3 billion or USD 7.2 billion.[2]
The total Offer consideration consists of a combination of cash and Mylan Shares. Subject to the potential adjustment to the composition of the Offer consideration as described below, Mylan is offering each Meda shareholder:
in respect of 80 percent of the number of Meda shares tendered by such shareholder, SEK 165 in cash per Meda share; and
in respect of the remaining 20 percent of the number of Meda shares tendered by such shareholder:
(i) if the volume-weighted average sale price per Mylan Share on the NASDAQ Global Select Stock Market for the 20 consecutive trading days ending on and including the second trading day prior to the Offer being declared unconditional (the "Offeror Average Closing Price") is greater than USD 50.74, a number of Mylan Shares per Meda share equal to SEK 165 divided by the Offeror Average Closing Price as converted from USD to SEK at a SEK/USD exchange rate of 8.4158;
(ii) if the Offeror Average Closing Price is greater than USD 30.78 and less than or equal to USD 50.74, 0.386 Mylan Shares per Meda share; or
(iii) if the Offeror Average Closing Price is less than or equal to USD 30.78, a number of Mylan Shares per Meda share equal to SEK 100 divided by the Offeror Average Closing Price as converted from USD to SEK at a SEK/USD exchange rate of 8.4158.
Substantial pre-tax annual operational synergies of approximately $350 million are expected to be achieved by year four after consummation of the Offer.
The transaction is expected to be immediately accretive to Mylan earnings, with accretion increasing significantly after the first full year (2017) as synergies are realized. The transaction creates an opportunity to achieve $0.35 to $0.40 accretion in 2017 and to accelerate achievement of Mylan’s previously stated $6.00 in adjusted diluted EPS target in 2017 versus 2018.[3]
The Board of Directors of Meda unanimously recommends that Meda shareholders accept the Offer.[4] The Meda Board of Directors has obtained a fairness opinion from SEB Corporate Finance, Skandinaviska Enskilda Banken AB ("SEB Corporate Finance") regarding the Offer stating that the Offer is fair from a financial point of view to the shareholders of Meda.
Stena Sessan Rederi AB ("Stena") and Fidim S.r.l. ("Fidim"), which own approximately 21 percent and 9 percent, respectively, of the outstanding shares and votes of Meda, have undertaken to accept the Offer, subject to certain conditions.
The Offer is not subject to any financing conditions. Mylan will finance the cash portion of the Offer consideration through a new bridge credit facility arranged by Deutsche Bank Securities Inc. and Goldman Sachs Bank USA.
Mylan intends to list the Mylan Shares to be issued in the Offer on the NASDAQ Global Select Market in the United States and the Tel Aviv Stock Exchange in Israel.
The Offer is subject to the satisfaction of a number of customary conditions, including clearance from relevant competition authorities. The Offer is not subject to approval by Mylan shareholders.
The Offer is expected to close by the end of the third quarter of 2016 (with the acceptance period of the Offer is expected to run from 20 May 2016 to 29 July 2016).
Background and reasons for the Offer
Mylan believes the transaction has a compelling strategic fit. In an environment where scale and reach are becoming increasingly important, a combination of Mylan and Meda will create a platform for sustainable, long-term growth:
The combined company will be a diversified global pharmaceutical leader, with a strong presence across geographies, therapeutic categories and channels, and with the breadth, scale and diversity to drive durable growth for the long term.
Following completion of the acquisition of Meda, Mylan will have an enhanced financial profile with approximately USD 11.8 billion in combined 2015 sales and combined 2015 adjusted EBITDA of approximately USD 3.8 billion.
The combined business will have a balanced portfolio of more than 2,000 products across the branded/specialty, generics and OTC segments, sold in more than 165 markets around the world.
The transaction will build on Mylan’s recent acquisition of the Abbott non-U.S. developed markets specialty and branded generics business to create an unparalleled European platform for growth – one that is well-positioned to succeed in this dynamic and challenging region. The transaction also consolidates EpiPen Auto-Injector in Europe, providing greater opportunities to build the brand in this region.
The transaction delivers on Mylan’s long-stated commitment to develop a substantial presence in the OTC segment, by creating an approximately USD 1 billion global OTC business at close.
Mylan’s and Meda’s complementary therapeutic presence will create a scale player in respiratory / allergy, dermatology and pain products, providing greater opportunities for growth in these areas and maximizing the potential of future product launches.
By offering one of the industry’s broadest portfolios of products across all customer channels (e.g., specialty, generics and OTC), the combined company will be well-positioned to deliver greater value to customers, which is increasingly important in light of the evolving payor and distributor environment. The combined portfolio will be supported by an expansive global commercial infrastructure, with sales representatives operating in 60 countries. The combined company will retain significant control over its supply chain, operating one of the industry’s most extensive and highest-quality manufacturing and research and development platforms with approximately 60 facilities.
Substantial pre-tax annual operational synergies of approximately $350 million by year four after consummation of the Offer are expected to be realized as a result of savings associated with integration and optimization across cost components and functions, and through leveraging opportunities of the combined commercial platform. Components of these synergies include: (1) optimization of the combined commercial platform, (2) optimization of COGS through world-class supply chain, vertical integration and global sourcing excellence, (3) elimination of redundant general and administrative costs, including public company costs, and (4) cross-fertilization opportunities of the combined product portfolio.
The transaction is expected to be immediately accretive to Mylan earnings, with accretion increasing significantly after the first full year (2017) as synergies are realized. The transaction creates an opportunity to achieve $0.35 to $0.40 accretion in 2017 and to accelerate achievement of Mylan’s previously stated $6.00 in adjusted diluted EPS target in 2017 versus 2018.[5]
Mylan’s pro forma leverage at close is expected to be approximately 3.8x debt-to-adjusted EBITDA, and the significant free cash flows generated by the combined company will allow for rapid deleveraging. As a result, Mylan will retain ample financial flexibility to pursue additional external opportunities.
Mylan believes that the Offer is compelling given that:
the Offer consideration represents a meaningful premium for Meda shareholders;
at announcement, the total value of the Offer for all Meda shares, including Meda net debt, is approximately SEK 83.6 billion or USD 9.9 billion, which represents a multiple of approximately 8.9x 2015 adjusted EBITDA with synergies;[6]
if the Offer is completed, Meda shareholders will become shareholders of Mylan, which has a clear track record of creating shareholder value, with an annualized three year total shareholder return of approximately 20.7 percent;[7] and
the Offer is fully financed and not conditional on further due diligence.
In addition to the compelling value to shareholders, the acquisition of Meda by Mylan would offer substantial benefits to the other stakeholders of both companies. For example, the combination would provide a broader variety of opportunities to employees. The position of creditors, customers and suppliers would also be enhanced by the combined company’s scale and significant cash flows, and patients would receive improved access to high-quality medicine through increased scale across geographies and robust capabilities to drive innovation.
Management and employees
Mylan recognizes the exceptional capabilities and skills of Meda’s dedicated management and employees and looks forward to welcoming these individuals to Mylan. Further, Meda has infrastructure in a number of markets where Mylan currently has limited resources, including Sweden. To realize the synergies discussed above, the integration of Mylan and Meda will likely entail some changes to the organization, operations and employees of the combined group. In the period following the completion of the Offer and following careful review of the needs of the combined business, Mylan will determine the optimal structure of the combined company to continue to deliver success in the future. Before completion of the Offer it is too early to say which measures will be taken and the impact these would have. There are currently no decisions on any material changes to Mylan’s or Meda’s employees and management or to the existing organization and operations, including the terms of employment and locations of the business.
The Offer
At announcement, the Offer consideration values each Meda share at SEK 165 and the total equity value of the Offer for all Meda shares is approximately SEK 60.3 billion or USD 7.2 billion.[8]
The total Offer consideration consists of a combination of cash and Mylan Shares. Subject to the adjustment to the composition of the Offer consideration as described below, Mylan is offering each Meda shareholder:
in respect of 80 percent of the number of Meda shares tendered by such shareholder, SEK 165 in cash per Meda share; and
in respect of the remaining 20 percent of the number of Meda shares tendered by such shareholder:
(i) if the Offeror Average Closing Price is greater than USD 50.74, a number of Mylan Shares per Meda share equal to SEK 165 divided by the Offeror Average Closing Price as converted from USD to SEK at a SEK/USD exchange rate of 8.4158;
(ii) if the Offeror Average Closing Price is greater than USD 30.78 and less than or equal to USD 50.74, 0.386 Mylan Shares per Meda share; or
(iii) if the Offeror Average Closing Price is less than or equal to USD 30.78, a number of Mylan Shares per Meda share equal to SEK 100 divided by the Offeror Average Closing Price as converted from USD to SEK at a SEK/USD exchange rate of 8.4158.
If the aggregate number of Mylan Shares that otherwise would be required to be issued by Mylan as described above exceeds 28,214,081 Mylan Shares (the "Share Cap"),[9] then Mylan will have the option (in its sole discretion) to (a) issue Mylan Shares in connection with the Offer in excess of the Share Cap and thus pay the share portion of the Offer consideration as described above (i.e. the 20 percent set out above), (b) increase the cash portion of the Offer consideration (so that it becomes larger than the 80 percent set out above) and thus correspondingly decrease the share portion of the Offer consideration (so that it becomes smaller than the 20 percent set out above) such that the aggregate number of Mylan Shares issuable by Mylan in connection with the Offer would equal the Share Cap or (c) execute a combination of the foregoing. The potential adjustment to the composition of the Offer consideration, together with illustrative examples, will be described in further detail in the offer document to be prepared for the Offer.
In short, each Meda shareholder will receive between SEK 152 and SEK 165 per Meda share in a combination of cash and Mylan Shares.[10]
Only whole Mylan Shares will be delivered to Meda shareholders who accept the Offer. Treatment of fractional shares will be described in the offer document to be prepared for the Offer.
If Meda pays dividends or makes any other distributions to its shareholders with a record date occurring prior to the settlement of the Offer, or issues new shares (or takes any similar corporate action) resulting in a reduction of the value per share in Meda prior to the settlement of the Offer, the Offer consideration will be reduced accordingly. The reduction shall first be made against the cash portion of the Offer consideration. Mylan reserves the right to determine whether this price adjustment mechanism or condition (vii) to the completion of the Offer shall be invoked. Notwithstanding the foregoing in this paragraph, Meda will be permitted to pay in 2016 its regular annual cash dividend in respect of Meda shares not exceeding SEK 2.5 per Meda share, with declaration, record and payment dates consistent with past practice, and such regular annual cash dividend shall not reduce the Offer consideration.
No commission will be charged in respect of the settlement of the Meda shares tendered to Mylan in the Offer.
The Offer is not subject to any financing conditions. The cash portion of the Offer consideration will be financed by a new bridge credit facility arranged by Deutsche Bank Securities Inc. and Goldman Sachs Bank USA.
At the time of this announcement Mylan does not hold any Meda shares or any financial instruments that give financial exposure to Meda shares, nor has Mylan acquired or agreed to acquire any Meda shares or any financial instruments that give financial exposure to Meda shares during the six months preceding the announcement of the Offer. For further information about the undertakings by each of Stena and Fidim to accept the Offer, please see "Undertakings to accept the Offer and shareholder agreements" below.
Share-based awards granted by Meda to employees under Meda’s incentive plans
The Offer does not include any share-based awards granted by Meda to its employees. Mylan intends to procure fair treatment in connection with the transaction for holders of such share-based awards.
Offer value and premium
At announcement, the total value of the Offer for all Meda shares, including Meda net debt, is approximately SEK 83.6 billion or USD 9.9 billion, which represents a multiple of approximately 8.9x 2015 adjusted EBITDA with synergies.[11]
The Offer represents a premium of:
approximately 9 percent compared to the 52-week intraday high of SEK 152.00 per Meda share on Nasdaq Stockholm on 13 April 2015 for the 52-week period up to and including 10 February 2016, the last trading day prior to the announcement of the Offer;
approximately 68 percent compared to the 90 calendar day volume-weighted average share price of SEK 98.50 per Meda share on Nasdaq Stockholm, up to and including 10 February 2016, the last trading day prior to the announcement of the Offer; and
approximately 92 percent compared to the closing share price of SEK 86.05 per Meda share on Nasdaq Stockholm on 10 February 2016, the last trading day prior to the announcement of the Offer.
Financing of the Offer
The aggregate cash consideration payable in the Offer for all Meda shares will be approximately SEK 48.2 billion (USD 5.7 billion).[12] The cash consideration will be financed by a new bridge credit facility arranged by Deutsche Bank Securities Inc. and Goldman Sachs Bank USA. The conditions to drawdown are usual and customary for a facility of this type.
Recommendation from the Board of Directors of Meda
The Board of Directors of Meda unanimously recommends that Meda shareholders accept the Offer.[13] The Meda Board of Directors has obtained a fairness opinion from SEB Corporate Finance regarding the Offer stating that the Offer is fair from a financial point of view to the shareholders of Meda.
Undertakings to accept the Offer and shareholder agreements
Undertakings to accept the Offer
Mylan has received irrevocable undertakings to accept the Offer from (1) Stena in respect of 75,652,948 Meda shares, representing approximately 21 percent of the outstanding shares and votes of Meda, and (2) Fidim in respect of 33,016,266 Meda shares, representing approximately 9 percent of the outstanding shares and votes of Meda. The irrevocable undertakings given by Stena and Fidim relate to their entire respective holdings of Meda shares. Each of Stena and Fidim has undertaken to accept the Offer no later than five business days prior to the expiry of the initial acceptance period of the Offer. The irrevocable undertakings given by Stena and Fidim shall be terminated if (i) a third party, prior to the Offer having been declared unconditional, makes a public offer to acquire all outstanding Meda shares at an offer value exceeding the value of the Offer by more than SEK 15 per share of Meda, (ii) the Offer is withdrawn, (iii) the Offer is not declared unconditional on or before 10 February 2017 or (iv) Mylan commits a material breach of applicable laws and regulations relating to the Offer.
Shareholder agreements
Each of Stena and Fidim has entered into a shareholder agreement with Mylan. Each shareholder agreement imposes certain restrictions on the applicable shareholder, including prohibiting transfers of Mylan Shares to competitors of Mylan and to activist investors (as defined in such shareholder agreement), as well as certain customary standstill limitations. Each shareholder agreement also imposes non-competition, non-solicitation and non-hire restrictions on the applicable shareholder for a period of 24 months after the Offer is declared unconditional. Each of Stena and Fidim has agreed pursuant to its applicable shareholder agreement to vote its Mylan Shares in accordance with the recommendation of the Mylan’s board of directors in the period up to and including the 180th day following settlement of the Offer and not vote its Mylan Shares against the recommendation of the Mylan’s board of directors in the period after the 180th day following settlement of the Offer, in each case subject to certain exceptions relating to significant corporate transactions. Each of Stena and Fidim has also agreed not to dispose of any Mylan Shares that it owns to any third party during the period up to and including the 180th day following the settlement of the Offer.
Conditions to the Offer
The Offer will be subject to the following conditions:
(i) the Offer being accepted to such an extent that Mylan becomes the owner of shares in Meda representing more than 90 percent of the total number of shares of Meda;
(ii) Mylan’s Registration Statement on Form S-4 in the United States, which will register the issuance of the Mylan Shares in the Offer, becoming effective under the Securities Act of 1933, as amended, and not being the subject of any stop order or proceeding seeking a stop order by the Securities and Exchange Commission (the "SEC");
(iii) the Mylan Shares to be issued in the Offer being approved for listing on the NASDAQ Global Select Market in the United States and the Tel Aviv Stock Exchange in Israel;
(iv) with respect to the Offer and the acquisition of Meda, receipt of all necessary regulatory, governmental or similar clearances, approvals and decisions, including from competition authorities, in each case on terms which, in Mylan’s opinion, are acceptable;
(v) no circumstances having occurred which could have a material adverse effect or could reasonably be expected to have a material adverse effect on Meda’s financial position or operation, including Meda’s sales, results, liquidity, equity ratio, equity or assets;
(vi) neither the Offer nor the acquisition of Meda being rendered wholly or partially impossible or significantly impeded as a result of legislation or other regulation, any decision of a court or public authority, or any similar circumstance;
(vii) Meda not taking any action that is likely to impair the prerequisites for making or completing the Offer;
(viii) no information made public by Meda or disclosed by Meda to Mylan being materially inaccurate, incomplete or misleading, and Meda having made public all information which should have been made public by it; and
(ix) no other party announcing an offer to acquire shares in Meda on terms more favorable to the shareholders of Meda than the Offer.
Mylan reserves the right to withdraw the Offer in the event it becomes clear that any of the above conditions is not satisfied or cannot be satisfied. With regard to conditions (ii) – (ix), however, such withdrawal will only be made to the extent permitted by applicable law if the non-satisfaction is of material importance to Mylan’s acquisition of the shares in Meda.
Mylan reserves the right to waive, in whole or in part, one or more of the conditions above, including, with respect to condition (i) above, to complete the Offer at a lower level of acceptance.
Brief description of Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, Mylan innovates to satisfy unmet needs; makes reliability and service excellence a habit; does what’s right, not what’s easy; and impacts the future through passionate global leadership. Mylan offers a growing portfolio of around 1,400 generic pharmaceuticals and several brand medications. In addition, Mylan offers a wide range of antiretroviral therapies, upon which nearly 50% of HIV/AIDS patients in developing countries depend. Mylan markets its products in approximately 165 countries and territories. Mylan’s global manufacturing and R&D platform includes more than 50 facilities, and Mylan is one of the world’s largest producers of active pharmaceutical ingredients. Every member of Mylan’s nearly 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more about Mylan at www.mylan.com.
Mylan is a public limited liability company (naamloze vennootschap) organized and existing under the laws of the Netherlands. Mylan’s corporate seat is located in Amsterdam, the Netherlands, its principal executive offices are located in Hatfield, Hertfordshire, England and Mylan N.V. group’s global headquarters are located in Canonsburg, Pennsylvania, United States. Mylan’s ordinary shares are traded on the NASDAQ Global Select Market and the Tel Aviv Stock Exchange under the symbol "MYL".
Listing of Mylan
Mylan intends to list the Mylan Shares to be issued in the Offer on the NASDAQ Global Select Market in the United States and the Tel Aviv Stock Exchange in Israel.
Due diligence
Mylan has conducted a limited confirmatory due diligence review of certain business, financial and legal information relating to Meda in connection with the preparation of the Offer. Meda has advised Mylan that, other than (a) certain unaudited internal budget information prepared by Meda’s management that will be included in the recommendation of the Offer by the Board of Directors of Meda to be published by Meda and (b) the year-end 2015 report that also will be published by Meda in connection with the publication of the recommendation of the Offer by the Board of Directors of Meda, Mylan has not received any information which has not been previously disclosed and which could reasonably be expected to affect the price of Meda shares in connection with the due diligence review.
Statement from the Swedish Securities Council in relation to the Offer
The Swedish Securities Council (Sw. Aktiemarknadsnämnden) (the Takeover Panel) has approved an extension of the period for preparing and filing the offer document with the Swedish Financial Supervisory Authority (the "SFSA") (Sw. Finansinspektionen) from four weeks after the announcement of the Offer to eight weeks after such date. The reasons for the extension are the time-consuming process of preparing pro forma financial statements and that Mylan has certain filing requirements with the SEC (see ruling AMN 2016:02). Mylan may request an additional extension if necessary.
Indicative timetable[14]
Estimated date for publication of the offer document: 19 May 2016
Estimated acceptance period: 20 May 2016 to 29 July 2016
Estimated settlement date: 5 August 2016
Mylan reserves the right to extend the acceptance period and, to the extent necessary and permissible, will do so in order for the acceptance period to cover applicable decision-making procedures at relevant authorities. Mylan also reserves the right to postpone the settlement date. Mylan will announce any extension of the acceptance period and/or postponement of the settlement date by a press release in accordance with applicable laws and regulations.
The acquisition of Meda is subject to approval from competition authorities. Relevant clearances are expected to be obtained prior to the end of the acceptance period.
Brief description of Meda
Meda is a leading international specialty pharma company with a broad product portfolio sold in more than 150 countries and 2015 sales of approximately SEK 19.65 billion. Meda employs approximately 4,500 people, including a robust salesforce and marketing organization of more than 2,600. Approximately 60 percent of Meda’s product sales are in the prescription area (Rx) and approximately 40 percent are in non-prescription (OTC) products. Approximately half of Meda’s revenues derive from products in three key therapeutic areas – respiratory, dermatology and pain. Some of Meda’s leading Rx products include Dymista (allergic rhinitis) and Elidel (atopic dermatitis); Meda also is Mylan’s commercial partner for EpiPen Auto-Injector in Europe. Meda’s leading OTC products include Dona (osteoarthritis), Saugella (women’s intimate hygiene) and CB12 (halitosis). Meda has a diversified geographic footprint with approximately 62 percent of Meda’s sales generated in Western Europe (the largest countries being Italy, Germany, France and Sweden), 19 percent in Emerging Markets (driven by China, Russia, the Middle East and Thailand) and 17 percent in the U.S. Meda has a network of seven manufacturing facilities in Europe, the U.S. and India. The Meda class A shares are listed under Large Cap on Nasdaq Stockholm. No Meda class B shares are outstanding. Learn more about Meda at www.meda.se.
Financial Effects for Mylan
The below unaudited financial information relates to information taken from each of Mylan’s and Meda’s reported financial results. Mylan’s historical financial statements have been reported in accordance with generally accepted accounting principles in the United States ("GAAP") while Meda’s historical financial statements have been reported in accordance with International Financial Reporting Standards as adopted by the EU and differences in accounting policies may occur. The below unaudited financial information is only an aggregation of each of Mylan’s and Meda’s reported financial information for the relevant time period in order to provide an illustration of the combined company’s revenues and earnings under the assumption that the activities were conducted within the same group from the beginning of the period presented.
The aggregation should not be viewed as pro forma since adjustments have not been made for the effects of the transaction, differences in accounting policies or transaction costs. The information set forth below does not necessarily reflect the results or the financial position that Mylan and Meda together would have had if they had conducted their operations as a group during the same period. For instance, expected synergies have not been taken into account. This information is also not indicative of what the combined company’s future earnings will be. Mylan currently intends to commence reporting consolidated accounts for the combined company after the closing of the transaction.

(in millions)

Full Year 2015
Mylan
Meda
Combined
Company[15]

USD
SEK[16]
USD[17]
SEK
USD
SEK
Revenues
9,429.3
79,594.6
2,327.6
19,648.0
11,756.9
99,242.6
Adjusted EBITDA
3,012.1[18]
25,425.7
767.9
6,482.0[19]
3,780.0
31,907.7

Pro forma financial information will be included in the offer document relating to the Offer, as well as in Mylan’s Registration Statement on Form S-4 to be filed with the SEC and Mylan’s EU Prospectus relating to the Offer, and may vary significantly from the combined financial information contained herein. The pro forma information included in the offer document relating to the Offer and Mylan’s EU Prospectus will be prepared in accordance with the applicable EU regulations, and the pro forma information included in Mylan’s Registration Statement on Form S-4 will be prepared in accordance with the applicable United States regulations, including the SEC’s rules; these two preparations may vary significantly from each other and from the combined financial information contained herein.
The Offer is not subject to any financing conditions. The cash portion of the Offer consideration will be financed by a new bridge credit facility arranged by Deutsche Bank Securities Inc. and Goldman Sachs Bank USA.
Compulsory acquisition and delisting
If Mylan becomes the owner of more than 90 percent of the Meda shares, Mylan intends to initiate a compulsory acquisition procedure with respect to the remaining Meda shares in accordance with the Swedish Companies Act. In connection therewith, Mylan intends to promote a delisting of the Meda shares from Nasdaq Stockholm.
Applicable law and disputes
The Offer will be governed by and construed in all respects in accordance with the substantive laws of Sweden, without regard to any conflict of law principles leading to the application of the laws of any other jurisdiction. Any dispute regarding the Offer, or which arises in connection therewith, shall be exclusively settled by Swedish courts, and the City Court of Stockholm (Sw. Stockholms tingsrätt) shall be the court of first instance.
Nasdaq Stockholm’s Takeover Rules (the "Takeover Rules") and the Swedish Securities Council’s (Sw. Aktiemarknadsnämnden) rulings and statements on the interpretation and application of the Takeover Rules are applicable to the Offer. Furthermore, Mylan has, in accordance with the Swedish Takeover Act (Sw. lagen om offentliga uppköpserbjudanden på aktiemarknaden), contractually undertaken towards Nasdaq Stockholm to comply with the Takeover Rules and to submit to any sanctions that can be imposed on Mylan by Nasdaq Stockholm in the event of a breach of the Takeover Rules.
Advisors
In connection with the Offer, Mylan has retained Centerview Partners as financial advisor, Cravath, Swaine & Moore LLP as legal advisor, Vinge as legal advisor in Sweden and NautaDutilh as legal advisor in the Netherlands.
_____________________________
Hertfordshire, England
10 February 2016 (CET)
Mylan N.V.
Mylan discloses the information provided herein pursuant to the Takeover Rules. The information was submitted for publication on 10 February 2016, 10:00 p.m. CET.
_____________________________
Information about the Offer
Information about the Offer is made available at: medatransaction.mylan.com.
Mylan’s management team will hold an investor conference call and webcast today, 10 February 2016, at 4:30 pm Eastern Time (10:30 pm Central European Time) to discuss the Offer, as well as Mylan’s financial results for the fourth quarter and year ended December 31, 2015 and its financial guidance for 2016. To participate in the conference call, please use the following dial-in:
Participant Toll-Free U.S. Dial-In Number: +1 800 514 4861
Participant International Dial-In Number: +1 678 809 2405
To access the live webcast, please log on to Mylan’s website, www.mylan.com, at least 15 minutes before the event is scheduled to begin to register and download or install any necessary software.
For further information: ENQUIRIES: Mylan N.V., Nina Devlin (Media), +1 724 514 1968; Kris King (Investors), +1 724 514 1813.
Additional information
In connection with the Offer, an offer document will be filed with the SFSA and published by Mylan upon approval by the SFSA. In addition, Mylan expects to file certain materials with the SEC, including, among other materials, a Registration Statement on Form S-4. Mylan also expects to file an EU Prospectus with the Netherlands Authority for the Financial Markets (the "AFM") or another competent EU authority. This communication is not intended to be, and is not, a substitute for such documents or for any other document that Mylan may file with the SFSA, the SEC, the AFM or any other competent EU authority in connection with the Offer. This communication contains advertising materials (reclame-uitingen) in connection with the Offer as referred to in Section 5:20 of the Dutch Financial Supervision Act (Wet op het financieel toezicht). INVESTORS AND SECURITYHOLDERS OF MEDA ARE URGED TO READ ANY DOCUMENTS FILED WITH THE SFSA, THE SEC AND THE AFM OR ANY OTHER COMPETENT EU AUTHORITY CAREFULLY AND IN THEIR ENTIRETY (IF AND WHEN THEY BECOME AVAILABLE) BEFORE MAKING AN INVESTMENT DECISION BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT MYLAN, MEDA AND THE OFFER. Such documents will be available free of charge through the website maintained by the SEC at www.sec.gov, on Mylan’s website at medatransaction.mylan.com or, to the extent filed with the AFM, through the website maintained by the AFM at www.afm.nl, or by directing a request to Mylan at +1 724 514 1813 or [email protected]. Any materials filed by Mylan with the SFSA, the SEC, the AFM or any other competent EU authority that are required to be mailed to Meda shareholders will also be mailed to such shareholders. A copy of this communication will be available free of charge at the following website: medatransaction.mylan.com.
Further information
The Offer, pursuant to the terms and conditions presented in this press release, is not being made to persons whose participation in the Offer requires that an additional offer document be prepared or registration effected or that any other measures be taken in addition to those required under Swedish law (including the Takeover Rules), Dutch law and U.S. law.
The distribution of this press release and any related Offer documentation in certain jurisdictions may be restricted or affected by the laws of such jurisdictions. Accordingly, copies of this communication are not being, and must not be, mailed or otherwise forwarded, distributed or sent in, into or from any such jurisdiction. Therefore, persons who receive this communication (including, without limitation, nominees, trustees and custodians) and are subject to the laws of any such jurisdiction will need to inform themselves about, and observe, any applicable restrictions or requirements. Any failure to do so may constitute a violation of the securities laws of any such jurisdiction. To the fullest extent permitted by applicable law, Mylan disclaims any responsibility or liability for the violations of any such restrictions by any person.
The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, any jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law (including the Takeover Rules), Dutch law and U.S. law.
The acceptance period for the Offer for shares of Meda described in this communication has not commenced.
Forward-looking information
This communication contains "forward-looking statements." Such forward-looking statements may include, without limitation, statements about the proposed transaction to acquire Meda, benefits and synergies of the proposed transaction, future opportunities for Mylan, Meda, or the combined company and products and any other statements regarding Mylan’s, Meda’s or the combined company’s future operations, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competition and other expectations and targets for future periods. These may often be identified by the use of words such as "will", "may", "could", "should", "would", "project", "believe", "anticipate", "expect", "plan", "estimate", "forecast", "potential", "intend", "continue", "target" and variations of these words or comparable words. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: uncertainties related to the proposed transaction, including as to the timing of the proposed transaction; uncertainties as to whether Mylan will be able to complete the proposed transaction; the possibility that competing offers will be made; the possibility that certain conditions to the completion of the Offer will not be satisfied; the possibility that Mylan will be unable to obtain regulatory approvals for the proposed transaction or be required, as a condition to obtaining regulatory approvals, to accept conditions that could reduce the anticipated benefits of the proposed transaction; the ability to meet expectations regarding the accounting and tax treatments of the proposed transaction, changes in relevant tax and other laws, including but not limited to changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; the integration of Meda being more difficult, time-consuming or costly than expected; operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients or suppliers) being greater than expected following the proposed transaction; the retention of certain key employees of Meda being difficult; the possibility that Mylan may be unable to achieve expected synergies and operating efficiencies in connection with the proposed transaction within the expected time-frames or at all and to successfully integrate Meda; expected or targeted future financial and operating performance and results; the capacity to bring new products to market, including but not limited to where Mylan uses its business judgment and decides to manufacture, market and/or sell products, directly or through third parties, notwithstanding the fact that allegations of patent infringement(s) have not been finally resolved by the courts (i.e., an "at-risk launch"); any regulatory, legal, or other impediments to Mylan’s ability to bring new products to market; success of clinical trials and Mylan’s ability to execute on new product opportunities; any changes in or difficulties with our inventory of, and our ability to manufacture and distribute, the EpiPen Auto-Injector to meet anticipated demand; the scope, timing and outcome of any ongoing legal proceedings and the impact of any such proceedings on financial condition, results of operations and/or cash flows; the ability to protect intellectual property and preserve intellectual property rights; the effect of any changes in customer and supplier relationships and customer purchasing patterns; the ability to attract and retain key personnel; changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan, Meda or the combined company; the inherent challenges, risks and costs in identifying, acquiring and integrating complementary or strategic acquisitions of other companies, products or assets and in achieving anticipated synergies; uncertainties and matters beyond the control of management; and inherent uncertainties involved in the estimates and judgments used in the preparation of financial statements, and the providing of estimates of financial measures, in accordance with GAAP and related standards or on an adjusted basis. For more detailed information on the risks and uncertainties associated with Mylan’s business activities, see the risks described in Mylan’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2015 and June 30, 2015 and its other filings with the SEC. These risks and uncertainties also include those risks and uncertainties that will be discussed in the offer document to be filed with the SFSA, the Registration Statement on Form S-4 to be filed with the SEC and the EU Prospectus to be filed with the AFM or another competent EU authority. You can access Mylan’s filings with the SEC through the SEC website at www.sec.gov, and Mylan strongly encourages you to do so. Mylan undertakes no obligation to update any statements herein for revisions or changes after the date of this communication, except as required by law.
Non-GAAP financial measures
This communication contains non-GAAP financial measures. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with GAAP.