On December 17, 2015 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) and OMT, Inc. (Open Monoclonal Technology) reported the signing of agreements for Ligand to acquire OMT, Inc., a leader in genetic engineering of animals for the generation of human therapeutic antibodies through its OmniAb platform (Press release, Ligand, DEC 17, 2015, View Source [SID1234517241]).

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OMT has leading antibody drug discovery technology and is believed to be the only company in the world offering three transgenic animal platforms for license. Its license agreements with biotechnology partners will initially add 16 shots on goal to Ligand, as well as future potential licensing deals and additional compounds generated from existing partnerships. OMT has existing licenses with Amgen, Celgene, Genmab, Janssen, Merck KGaA, Pfizer, Seattle Genetics, Five Prime, Symphogen and various other biotechnology and pharmaceutical companies. OMT is privately held and is majority owned by Essex Woodlands.

Under the terms of the transaction, Ligand will pay OMT shareholders approximately $178 million, including $92.6 million in cash and $85.4 million in Ligand common stock. Roland Buelow, Ph.D., founder of OMT and a world-renowned antibody researcher, is expected to join Ligand as Vice President of Antibody Technologies and continue working with Ligand on advancing the OMT business. The transaction is subject to customary closing conditions and is expected to close in January 2016.

"OMT is an ideal strategic fit for Ligand and holds potential to have a profoundly positive impact on our business over the long term," said John Higgins, Chief Executive Officer of Ligand Pharmaceuticals. "OMT brings a robust and important technology for biologic drug discovery that we believe will stand next to Captisol in terms of opportunity for partner events, new licensing transactions and financial contribution. The transaction is expected to be accretive to revenue and adjusted earnings, and if products are approved in the future, the underlying royalties could generate substantial revenues for decades to come. This transaction is a major addition to what Ligand believes is an unprecedented portfolio of more than 140 fully-funded partnered programs."

"OMT has created a highly successful business around the OmniAb antibody technology platform and the business has significant growth potential," said Roland Buelow, Ph.D., Chief Executive Officer of OMT. "We are very impressed with Ligand’s business model, success in deal making and commitment to continue driving the OMT business to even greater success. We believe Ligand’s broad licensing network, business acumen, financial resources and commitment to our technology create an attractive exit for OMT shareholders. I am personally excited to join Ligand as an employee and shareholder, and look forward to helping the talented team continue to expand its business."

OMT OmniAb Antibody Platform

OmniAb refers to three industry-recognized transgenic animal platforms for generation of naturally optimized monospecific, bispecific and polyspecific human therapeutic antibodies.

OmniRat is one of the industry’s first human monoclonal antibody technology based on rats. It has a complete immune system with a diverse antibody repertoire and is genetically engineered to produce antibodies with human idiotypes.

OmniMouse is a transgenic mouse that complements OmniRat and expands epitope coverage and therefore antibody discovery capabilities for partners.

OmniFlic is an engineered rat with a fixed light chain for development of bispecific, fully human antibodies.

All three platforms use patented technology and deliver fully human antibodies with high affinity, specificity, expression, solubility and stability, thereby facilitating more rapid discovery of therapeutic antibodies for partners. OmniAb allows partners to identify high-affinity antibodies in a patented animal system, that therefore have been optimized by in vivo selection pressures, accelerating development times and increasing the prospects of technical success compared with traditional antibody-generation technologies.

Antibodies are a major and growing segment of the pharmaceutical industry. Five of the top 10 selling medicines in 2014 were antibodies. The top 10 selling antibodies in 2014 generated total revenue of $57 billion and the number of antibodies in clinical development has tripled over the past seven years from 150 to 468 currently.

Acquisition Rationale

There are multiple aspects of this transaction that support the strategic rationale to Ligand, including:

1. Financial Contribution – Projected to be accretive to revenues and adjusted earnings with potential for significant financial contribution to Ligand through future royalties.

2. Portfolio Expansion – Major addition of new partners and fully-funded shots on goal. OMT is expected to initially bring to Ligand 16 new shots on goal, and Ligand is projected to have more than 140 fully-funded programs and more than 83 partners after the OMT transaction closes.

3. Technology Diversification – Diversification of Ligand’s technology offering for licensing. OmniAb is a broad and robust technology platform and is a key resource used by biotechnology companies to discover new biologic drugs. The OMT technology is expected to be a new pillar of Ligand’s business, standing alongside the Captisol drug-formulation technology. OmniAb will create a strong platform for Ligand to seek new licenses and partnerships.

4. Royalty Extension – Significant extension of potential patent protection period and royalty terms for Ligand-partnered programs. Patents for OMT technology run through 2033, but each newly discovered antibody may be the basis for its own novel intellectual property, resulting in patents for each antibody on a drug-by-drug basis that could extend past 2040.

Acquisition and OMT Business Highlights

Following are some of the highlights of the OMT business and their expected impact on Ligand:

OMT diversifies Ligand’s business by adding a proprietary antibody-generating platform, giving Ligand further exposure to an important segment of the pharmaceutical industry. OMT has three distinct transgenic rodent systems for generating antibodies: OmniRat, OmniMouse and OmniFlic.
Ligand projects up to three antibodies from the OMT platform will be in human Phase 1 trials by the end of 2017 and as many as 15 antibodies could be in Phase 1 or more advanced trials by 2020.
OMT OmniAb licenses have generally been structured with a combination of license fees, annual technology access fees, milestone payments and royalties. Royalties are generally in the low- to mid-single digits. The existing OMT portfolio is comprised of platform licenses with high-quality companies.
With the acquisition, Ligand is acquiring 16 platform partnerships and antibody-specific licenses. Following the transaction, Ligand will have partnerships with 83 different companies and over 140 fully funded programs with each OMT platform deal currently counting as one shot on goal.
The OMT business is projected to add $6 million and $12 million of revenues to Ligand in 2016 and 2017, respectively. This revenue is based on existing licensing contracts and potential payments, and does not include revenue from potential new partnerships and programs. Annual expenses to operate the OMT business are projected to be between $3 million and $5 million.
The acquisition of the existing OMT business and licenses will accelerate Ligand’s projected financial growth. The transaction is projected to add 5% to 2016 revenue and 7% to 10% to annual revenue over the next decade, after which time initial royalty-bearing products could be approved with contribution to revenue growth being potentially much greater thereafter. The transaction is projected to be slightly accretive to adjusted EPS in 2016 and accretive to adjusted EPS by approximately 4% to 8% per year over the next several years.
Ligand Pro Forma 2016 and 2017 Financial Outlook

Including this acquisition, Ligand expects 2016 total revenues to be between $113 million and $117 million. This guidance assumes approximately $6 million of revenue from the OMT business in 2016, and approximately $107 million to $111 million of revenue from the original Ligand business. Ligand’s pro forma 2016 cash operating expenses are expected to be between $26 million and $28 million. In 2016, adjusted EPS is projected to be unchanged and in the range of $3.33 to $3.38.

For 2017, Ligand expects total revenues to exceed $158 million with adjusted EPS of more than $4.95. This guidance assumes approximately $12 million of revenue from the OMT business in 2017, and approximately $0.20 of incremental EPS contribution from the acquisition.

OMT non-cash amortization expense estimates are expected to be determined in the near term. Amortization charges will be recognized in GAAP EPS and the non-cash charge will be excluded from adjusted EPS.

Adjusted Financial Measures

The adjusted financial measures discussed above exclude changes in contingent liabilities, mark-to-market adjustment for amounts owed to licensors, non-cash stock-based compensation expense, non-cash debt-related costs, pro-rata non-cash net losses of Viking Therapeutics, non-cash OMT purchase price amortization and non-cash tax expense.

Ligand believes that the presentation of adjusted financial measures provides useful supplementary information to investors and reflects amounts that are more closely aligned with the cash profits for the period as the items that are excluded from adjusted net income are all non-cash items. Ligand uses these adjusted financial measures in connection with its own budgeting and financial planning. These adjusted financial measures are in addition to, and not a substitute for, or superior to, measures of financial performance prepared in conformity with GAAP.

On December 17, 2015 The European Medicines Agency (EMA) reported that it has recommended granting a conditional marketing authorisation for Tagrisso (osimertinib) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a specific mutation (T790M) of the epidermal growth factor receptor (EGFR) (Press release, Curis, DEC 17, 2015, View Source;mid=WC0b01ac058004d5c1 [SID:1234508640]).

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Lung cancer is among the most common cancers in the world. In Europe, in 2012, 313,000 patients were newly diagnosed and 268,000 people died from the disease, accounting for one in five cancer deaths. Approximately 80-90% of all lung cancers are NSCLCs, which occur when cancer cells form in the tissues of the lung. EGFR is a protein involved in the growth and spread of cancer cells.

Despite progress in early detection and treatment, NSCLC is most often diagnosed at an advanced stage and the outlook for patients with the disease is poor. Once NSCLC has progressed to a locally advanced or metastatic stage, treatment is focused on extending life, delaying disease progression and improving symptoms and quality of life.

Tagrisso is a tablet that should be taken orally once per day. It is intended for patients who have developed a mutation in the EGFR gene. Mutations of the EGFR gene may develop in tumours and reduce the effect of EGFR-blocking medicines. Tagrisso is intended for use in tumours with one such mutation, T790M.

The Committee for Medicinal Products for Human Use (CHMP) reviewed Tagrisso under EMA’s accelerated assessment program and recommended conditional approval for the medicine. These are two of the Agency’s main mechanisms to facilitate earlier access by patients to medicines that fulfill unmet medical needs. Conditional approval allows EMA to recommend a medicine for marketing authorisation before the availability of confirmatory clinical trial data, if the benefits of making this medicine available to patients immediately outweigh any risks related to the lack of comprehensive data.

The safety and efficacy of Tagrisso were demonstrated in two single-arm phase II trials involving a total of 411 patients with advanced EGFR T790M mutation-positive NSCLC whose disease progressed after treatment with EGFR-blocking therapies.

Results from these two trials showed that a high proportion of patients (around 66%) responded and their tumour shrunk. This response appeared to be long-lasting. The benefits in terms of progression free survival and/or overall survival have not yet been determined.

The most common side effects of Tagrisso are diarrhoea and skin and nail conditions such as dry skin, rash and acne.

As part of the conditional marketing authorisation, the applicant for Tagrisso must provide results from an ongoing phase III study. Until availability of full data, the CHMP will review the benefits and risks of Tagrisso annually to determine whether the conditional marketing authorisation can be maintained.

The opinion adopted by the CHMP at its December 2015 meeting is an intermediary step on Tagrisso’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, each Member State will take a decision on price and reimbursement based on the potential role/use of this medicine in the context of its national health system.

On December 17, 2015 OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, reported that the European Commission has granted orphan drug designation to OXi4503 for the treatment of acute myeloid leukemia (AML) (Press release, OXiGENE, DEC 17, 2015, View Source [SID:1234508604]). The designation provides for ten years of marketing exclusivity in EU member countries following product approval. OXi4503 has previously received orphan drug designation from the U.S. Food and Drug Administration, which provides for seven years of marketing exclusivity after approval.

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"The European Commission’s decision highlights the need for new AML treatment options and improves the commercial potential of OXi4503," stated William D. Schwieterman, M.D. President and Chief Executive Officer of OXiGENE. "We have recently put plans in place to accelerate the development of this promising agent by immediately advancing into the next phase of our ongoing phase 1b/2 clinical trial in the U.S., in which OXi4503 will be used in combination with the approved AML drug cytarabine instead of as a stand-alone investigational agent for the treatment of refractory AML."

Orphan designation in the European Union is granted to product candidates that are intended to treat life-threatening or chronically-debilitating conditions that affect no more than five patients per 10,000 of the EU population. Among other benefits, orphan designation provides for regulatory assistance and scientific advice from the European Medicines Agency during product development.

About OXiGENE

OXiGENE is a clinical-stage biopharmaceutical company developing vascular disrupting agents (VDAs) to treat cancer. VDAs selectively disrupt abnormal blood vessels that sustain tumors. The company’s investigational drugs include CA4P (fosbretabulin), which is in development as a treatment for solid tumors, and OXi4503, which is in development for acute myeloid leukemia (AML). OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.

On December 17, 2015 Bristol-Myers Squibb Company (NYSE:BMY) and The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) reported that they have entered into a collaborative agreement as part of Bristol-Myers Squibb’s Immuno-Oncology Rare Population Malignancy (I-O RPM) program in the U.S (Press release, Bristol-Myers Squibb, DEC 17, 2015, View Source [SID:1234508602]). The I-O RPM program is a multi-institutional initiative with academic-based cancer centers focused on the clinical investigation of immuno-oncology therapeutics as potential treatment options for patients with high risk, poor prognostic cancers, defined as a rare population malignancy.

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As part of the I-O RPM program, Bristol-Myers Squibb and OSUCCC – James will conduct a range of early phase clinical studies, and Bristol-Myers Squibb will fund training positions within the Hematology and Medical Oncology fellowship programs of the Ohio State University College of Medicine, Department of Internal Medicine.

"Immuno-oncology is rapidly evolving with the potential to play a significant role in the treatment of a broad range of cancers and we are committed to finding innovative and efficient ways to further the science, research and development of these compounds for patients," said Laura Bessen, M.D., head of U.S. Medical, Bristol-Myers Squibb. "OSCUCC- James is a leading cancer research institution with a shared goal of improving outcomes for patients and we look forward to our collaboration through the I-O RPM program."

"It is clear based on existing and emerging scientific data that immuno-oncology therapeutics, which harness the patient’s own immune system to attack cancer cells, have tremendous potential to tailor patient treatments based on the individual’s unique tumor characteristics, and this clinical research partnership has the potential to give our patients – both locally and who travel here from across the globe – access to some of the most novel treatments available," said Richard Goldberg, M.D., Physician-in-Chief at The OSUCCC – James.

About I-O RPM

Immuno-oncology is an innovative approach to cancer research and treatment that is designed to harness the body’s own immune system to fight cancer. The I-O RPM research program focuses on significant areas of high unmet need marked by poor outcomes among patients with rare population malignancies. A rare population malignancy is a subpopulation within a higher incident disease population. These patients have aggressive disease with an increased potential for early metastasis to multiple sites and/or are initially refractory or subject to early recurrences with conventional cancer therapies. Existing clinical research provide a strong rationale for further research into the potential of immunotherapies for these cancers.

The I-O RPM research program is a multi-institutional initiative with Robert H. Lurie Comprehensive Cancer Center of Northwestern University and the Northwestern Medicine Developmental Therapeutics Institute, Moffitt Cancer Center, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, UCLA and now OSUCCC – James. I-O RPM builds on Bristol-Myers Squibb’s formation in 2012 of the International Immuno-Oncology Network (II-ON), which is a global collaboration between Bristol-Myers Squibb and academia focused on facilitating the translation of scientific research findings into clinical trials and, eventually, clinical practice.