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PROMETIC ANNOUNCES CLOSING OF TELESTA THERAPEUTICS INC. ACQUISITION

On October 31, 2016 ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("ProMetic" or the "Corporation") reported today that it has closed the acquisition of all the issued and outstanding common shares of Telesta Therapeutics, Inc, ("Telesta") by way of a plan of arrangement under the Canada Business Corporations Act (the "Acquisition") for a consideration of $0.14 per Telesta common share payable in ProMetic common shares (Press release, ProMetic Life Sciences, OCT 31, 2016, View Source [SID1234516121]).

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The number of common shares to be issued by ProMetic is based on the volume-weighted average closing price ("VWAP") of ProMetic’s common shares for the five (5) trading days prior to the closing date of the Acquisition. At the end of trading on the Toronto Stock Exchange on Friday, October 28, 2016, the 5 day VWAP of ProMetic’s common shares was $2.98. Accordingly, each Telesta common share was acquired for 0.04698 ProMetic common share.

Pierre Laurin, President and CEO of ProMetic stated: "We welcome Telesta’s shareholders decision to participate to ProMetic’s growth as they will benefit from our ability to further leverage Telesta’s assets. ProMetic represents a balanced, low-risk, high reward opportunity as we are getting ready to launch our first plasma-derived therapeutic, plasminogen, in mid-2017 followed by the sequential launches of several other plasma-derived products from our proprietary manufacturing platform. Furthermore, our small molecule fibrosis program is set to contribute further significant upside now that PBI-4050’s efficacy in humans has been demonstrated", added Mr. Laurin.

"Closing this transaction is both strategically and tactically significant for ProMetic for many reasons", commented Bruce Pritchard, Chief Operating Officer. He added, "It brings cash which extends our operating runway; a small group of key personnel who are highly complementary to our existing staff; tax losses to be used going forward; and lastly, a facility located in Belleville, Ontario with a recently refurbished part that could add quickly to our existing manufacturing output and in the longer term, the potential to provide additional plasma processing capacity. It also widens our trans-Canadian footprint, positioning us as a major supplier of plasma proteins to the Canadian market".

Concurrently with the Acquisition, the Corporation has closed a private placement entered into with Structured Alpha LP ("SALP"), an investment vehicle of Peter J. Thomson. This concurrent private placement was completed in connection with the exercise by SALP of its pre-emptive right. The private placement is for the subscription of 1,401,632 common shares of the Corporation at a price of $2.98 per common share. The proceeds from this private placement have been used to offset and reduce the total amount owed by ProMetic to SALP under its second amended and restated loan agreement by $4,176,863.36.

DURECT Corporation Announces Third Quarter 2016 Financial Results and Update of Programs

On October 31, 2016 DURECT Corporation (Nasdaq: DRRX) reported financial results for the third quarter of 2016. Total revenues were $3.7 million and net loss was $8.8 million for the three months ended September 30, 2016 as compared to total revenues of $4.7 million and net loss of $6.5 million for the three months ended September 30, 2015.
At September 30, 2016, we had cash and investments of $29.0 million, compared to cash and investments of $29.3 million at December 31, 2015. At September 30, 2016, we had $19.8 million in long term debt.
"We are pleased to have provided a separate update today on our DUR-928 program," stated James E. Brown, D.V.M., President and CEO of DURECT. "Regarding POSIMIR, we have switched over the majority of our active clinical trial sites in the PERSIST Phase 3 trial from Part 1 to Part 2, in which POSIMIR is compared head-to-head against bupivacaine HCL, and continue to add new sites as enrollment proceeds."
Update of Selected Programs:

• Epigenetic Regulator Program. DUR-928, our Epigenetic Regulator Program’s lead product candidate, is an endogenous, small molecule, new chemical entity (NCE), which may have broad applicability in several metabolic diseases such as nonalcoholic steatohepatitis (NASH), and in acute organ injuries such as acute kidney injury.
As reported in greater detail in a separate press release today, our first Phase 1b clinical trial in patients has progressed to the second cohort with a higher dose. While this study was not designed to assess the efficacy of DUR-928 as a therapy for NASH, we are pleased to be able to report that certain biomarkers for liver function and liver injury were reduced in the first cohort 12 hours after a single dose of DUR-928 as compared to before dosing. Collectively, the reduction of these biomarkers plus results from our animal and cell culture studies suggest potential therapeutic activity of DUR-928 for patients with liver disease. However, additional studies are required to evaluate the safety and efficacy of DUR-928, and there is no assurance that these biomarker effects will be observed in a statistically significant manner, or that DUR-928 will demonstrate safety or efficacy in treating NASH or other liver diseases in larger controlled trials. We have recently requested a pre-IND meeting with the U.S. Food and Drug Administration (FDA) as precursor to submitting an IND, which is required to enable a future liver disease clinical trial in the United States.
Our second Phase 1b clinical study with DUR-928, in patients with impaired kidney function (stage 3 and 4 chronic kidney disease), is underway in Australia. We recently held a pre-IND meeting with the Cardiovascular and Renal Products Division of the FDA; we anticipate utilizing feedback from that meeting as well as from our clinical advisors to file an IND which is required to enable a future kidney disease clinical trial in the United States.
• POSIMIR (SABER-Bupivacaine) Post-Operative Pain Relief Depot. POSIMIR is our investigational post-operative pain relief depot that utilizes our patented SABER technology and is intended to deliver bupivacaine to provide up to 3 days of pain relief after surgery. We are in discussions with potential partners regarding licensing development and commercialization rights to POSIMIR, for which we hold worldwide rights. We are also continuing to evaluate the requirements for commercializing POSIMIR on our own in the U.S., in the event that we determine that to be the preferred route of commercialization.
In November 2015, we began enrolling patients for PERSIST, a POSIMIR Phase 3 clinical trial consisting of patients undergoing laparoscopic cholecystectomy (gallbladder removal) surgery. We began recruiting patients for this trial comparing POSIMIR to placebo. Based on recommendations from the FDA received subsequent to the start of the trial, in April 2016 we decided to amend the PERSIST trial. Starting in August 2016, we began implementing Part 2 of the PERSIST trial to evaluate POSIMIR against standard bupivacaine HCl rather than placebo as we have been doing in Part 1. We expect to enroll approximately 264 patients in Part 2 of PERSIST, and we expect this part of the trial to finish dosing patients in the third quarter of 2017. We believe that a positive outcome from this new trial design would result in a stronger NDA resubmission and potential commercial advantages. In a previous clinical trial of 50 patients in the same surgical model (laparoscopic cholecystectomy), POSIMIR was compared with the active control bupivacaine HCl, against which POSIMIR demonstrated in a post hoc analysis an approximately 25% reduction in pain intensity on movement for the first 3 days after surgery (p=0.024) and for the first 2 days after surgery (p=0.0198), using the same statistical methodology specified for the current trial. There can be no assurance that the PERSIST trial will replicate these results.

• REMOXY ER (oxycodone) Extended-Release Capsules CII. Based on our ORADUR technology, the investigational drug REMOXY ER is a unique long-acting formulation of oxycodone designed to discourage common methods of tampering associated with opioid misuse and abuse.
In September 2016, Pain Therapeutics (our licensee) received a Complete Response Letter from the FDA for REMOXY ER. Based on its review, the FDA has determined that the NDA cannot be approved in its present form and specifies additional actions and data that are needed for drug approval. Pain Therapeutics has stated that it is evaluating the comments raised by the FDA and is consulting with outside experts.

• ORADUR-ADHD Program. ORADUR-Methylphenidate is an investigational drug that has the potential for rapid onset of action, long duration with once-a-day dosing, utilizes a small capsule size relative to the leading existing long-acting products on the market and incorporates our ORADUR anti-tampering technology. Orient Pharma, our licensee in defined Asian and South Pacific countries, has initiated a Phase 3 study in Taiwan and anticipates completing dosing the trial in 2016. We retain rights to all other markets in the world, notably including the U.S., Europe and Japan, and are engaged in licensing discussions with other companies.
• Business Development Activities. We have multiple programs that may potentially be licensed over the next 12-18 months. These include POSIMIR, DUR-928, ORADUR-ADHD (territories outside certain Asian and South Pacific markets), as well as various other programs which we have not described publicly in detail.

• Debt Refinancing. In July 2016, we refinanced our existing $20 million term loan with Oxford Finance into a new term loan that results in an extended maturity (to four years) and an extended interest only period (to 18 months).

• Upcoming investor conference. DURECT will be presenting at the Stifel Nicolaus Healthcare Conference at 4:30 pm Eastern time on November 15. The conference is being held at the New York Palace Hotel in New York. A live audio webcast of the presentation will be available by accessing View Source A live audio webcast of these presentations will also be available by accessing DURECT’s homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under Audio Archive in the "Investor Relations" section.

Celsion Presents Data on ThermoDox® plus Optimized RFA in Intermediate Primary Liver Cancer at the 3rd Asian Conference on Tumor Ablation (ACTA)

On October 31, 2016 Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, reported the presentation of data from the Company’s HEAT Study, highlighting the curative potential for ThermoDox plus optimized radiofrequency ablation (RFA) in intermediate primary liver cancer, also known as hepatocellular carcinoma (HCC) (Press release, Celsion, OCT 31, 2016, View Source [SID1234516112]). The clinical data were presented by a leading liver cancer expert from South Korea, Professor Won Young Tak, M.D., Ph.D., Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea, on October 29, 2016 at the 3rd Asian Conference on Tumor Ablation (ACTA) in Seoul, Korea. Dr. Hyunchul Rhim from Samsung Medical Center in Soeul, Korea, is the Chairman of the 3rd ACTA Conference and a principal investigator on the Company’s OPTIMA Study.

Professor Tak’s presentation, entitled "Thermo-Sensitive Drug Assisted Ablation," highlighted data from Celsion’s latest HEAT Study post-hoc analysis, which suggests an overall survival benefit of over two years in the large subgroup of patients treated with ThermoDox plus optimized RFA (RFA ≥ 45 minutes) as well as findings from preclinical studies demonstrating a direct correlation between the duration of RFA heating, or dwell time, and the concentration of doxorubicin localized to the liver.

"There is clear evidence that the duration of the RFA regimen is critical when treating patients with ThermoDox, and the totality of the data presented to date demonstrate that ThermoDox plus optimized RFA has a strong potential to serve as a curative therapy for patients with liver cancer," said Professor Tak, lead investigator in South Korea for the Company’s HEAT and OPTIMA studies. "The OPTIMA trial is designed to validate this approach in an indication where there exists a strong unmet need for effective treatment options."

The Phase III OPTIMA study is a global pivotal, double-blind, placebo-controlled study evaluating ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus standardized RFA alone.

"Our OPTIMA Study investigators continue to recognize the value of findings from the HEAT study, and their continued interest reinforces substantial and mounting support for and the de-risking of our ongoing global Phase III OPTIMA Study," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "The recent independent analysis conducted by the National Institutes of Health provides further confirmatory support indicating that the use of RFA for more than 45 minutes in patients treated with ThermoDox can have a correlative impact on reductions in tumor size and overall survival in patients with primary liver cancer."

Professor Tak’s presentation will be available on Celsion’s website under "News & Events – Scientific Presentations."
Celsion notes that NIH’s analysis will be discussed in detail during an oral session on Monday, November 28, 2016 at 1:50 pm CT during the 102nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) to be held on November 26 – December 2, 2016 in Chicago, IL.

About Celsion’s Phase III OPTIMA Study
Celsion’s Phase III OPTIMA Study is a global pivotal, double-blind, placebo-controlled study. The study is expected to enroll up to 550 patients in over 75 clinical sites in the North America, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus standardized RFA alone. The primary endpoint for the trial is overall survival, which is supported by post-hoc analysis of data from the Company’s 701 patient HEAT Study, where optimized RFA has demonstrated the potential to significantly improve survival when combined with ThermoDox. The statistical plan for the OPTIMA Study calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC).

Cardinal Health Reports First-quarter Results for Fiscal Year 2017

On October 31, 2016 Cardinal Health (NYSE: CAH) reported first-quarter fiscal year 2017 revenue of $32 billion, an increase of 14 percent from the comparable quarter last yea (Press release, Cardinal Health, OCT 31, 2016, View Source [SID1234516111])r. The company also reported a decline in GAAP operating earnings of 14 percent to $535 million and in non-GAAP operating earnings of 9 percent to $669 million. GAAP diluted earnings per share (EPS) decreased 17 percent to $0.96, while non-GAAP diluted EPS decreased 10 percent to $1.24.

"Our first-quarter results were largely as we suggested they would be, with a healthy increase in revenue and a decrease in our operating earnings largely driven by conditions in the pharmaceutical distribution market," said George Barrett, chairman and CEO of Cardinal Health. "While short-term headwinds, particularly around pharmaceuticals, are quite challenging, our Medical segment had an excellent quarter building on the momentum coming out of fiscal year 2016. From an operating perspective, our metrics were strong in both of our reporting segments, and our strategic positioning is well-aligned with the changing needs of the market."

Q1 FY17 summary

Q1 FY17

Q1 FY16

Y/Y
Revenue
$
32.0
billion

$
28.1
billion

14%
Operating earnings
$
535
million

$
620
million

(14)%
Non-GAAP operating earnings
$
669
million

$
737
million

(9)%
Net earnings attributable to Cardinal Health Inc.
$
309
million

$
383
million

(19)%
Non-GAAP net earnings attributable to Cardinal Health Inc.
$
399
million

$
458
million

(13)%
Diluted EPS attributable to Cardinal Health Inc.
$
0.96

$
1.15

(17)%
Non-GAAP diluted EPS attributable to Cardinal Health Inc.
$
1.24

$
1.38

(10)%
Segment results
Pharmaceutical segment
First-quarter revenue for the Pharmaceutical segment increased 14 percent to $28.8 billion due to growth from net new and existing Pharmaceutical Distribution customers and, to a lesser extent, performance from the Specialty business.
Segment profit for the quarter decreased 19 percent to $534 million. This decrease was driven by generic pharmaceutical pricing and, to a lesser extent, reduced levels of branded inflation and the previously announced loss of a large Pharmaceutical Distribution customer. This was partially offset by solid performance from Red Oak Sourcing.

Q1 FY17

Q1 FY16

Y/Y
Revenue
$
28.8
billion

$
25.1
billion

14%
Segment profit
$
534
million

$
657
million

(19)%

Cardinal Health
Page 2

Medical segment
First-quarter revenue for the Medical segment increased 12 percent to $3.3 billion driven by contributions from acquisitions and net new and existing customers.
Segment profit increased 26 percent to $127 million due to contributions from acquisitions and Cardinal Health Brand products.

Q1 FY17

Q1 FY16

Y/Y
Revenue
$
3.3
billion

$
2.9
billion

12%
Segment profit
$
127
million

$
101
million

26%
Fiscal 2017 outlook
The company does not provide GAAP EPS outlook, because it is unable to reliably forecast most of the items that are excluded from GAAP EPS to calculate non-GAAP EPS. These items could cause EPS to differ materially from non-GAAP EPS. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

Full-year Pharmaceutical segment profit is now expected to be down as a percentage in the mid-to-high single digits compared to fiscal year 2016, with the changes coming primarily from generic pharmaceutical pricing and, to a lesser extent, reduced levels of branded inflation. Based on first-quarter results and second-quarter expectations, the company slightly lowered its fiscal year 2017 guidance range for non-GAAP diluted EPS from continuing operations to $5.40 to $5.60 from $5.48 to $5.73, representing growth of approximately 3 to 7 percent from the prior year.

More details about this outlook can be found on the company’s webcast and accompanying slides; see below for details.
Additional first-quarter and recent highlights
•
Onboarded Medical segment customer Kaiser Permanente
•
Expanded the existing distribution agreement between Cordis and Biosensors, enabling Cordis to be the exclusive distributor for Biosensors’ coronary interventional products in Japan
•
Acquired TelePharm, a company that focuses on establishing telepharmacies in rural areas
•
Granted Cardinal Health Foundation funds to 17 community-based non-profit organizations nationwide to combat prescription drug misuse

Selecta Biosciences Collaborators at the National Cancer Institute Present Preclinical Data Showing SVP-Rapamycin Application to Cancer Therapy

On October 31, 2016 Selecta Biosciences, Inc. (NASDAQ:SELB), a clinical-stage biopharmaceutical company developing a novel class of targeted antigen-specific immune therapies, reported that results from preclinical studies involving SVP-Rapamycin, the company’s novel immunotherapeutic, were presented by its collaborators Ira Pastan, MD, Chief of the Laboratory of Molecular Biology, and Ronit Mazor, Ph.D., Postdoctoral Fellow at Center for Cancer Research at the National Cancer Institute (NCI), part of the National Institutes of Health (Press release, Selecta Biosciences, OCT 31, 2016, View Source [SID1234516120]).

Through a collaboration under a Cooperative Research and Development Agreement (CRADA) between Selecta and NCI, the results were obtained by co-administration of SVP-Rapamycin with an investigational anti-cancer therapeutic, LMB-100. LMB-100 is a next-generation recombinant immunotoxin (rIT) developed in the Pastan Lab that is currently undergoing Phase 1 clinical trials at the NIH Clinical Center in patients with mesothelioma and pancreatic cancer.

Dr. Pastan’s presentation at the Immunogenicity and Bioassay Summit 2016 in Baltimore, Maryland was entitled, "Strategies to Reduce Immune Response to Immunotoxins," and Dr. Mazor’s presentation was entitled, "Induction of Tolerance to Immunotoxins Using Nanoparticle Delivery of Rapamycin." Further, Dr. Mazor presented a poster with the title "Nanoparticle-Encapsulated Rapamycin Prevents Primary and Secondary Immune Responses in Murine Models."

LMB-100 is a next-generation immunotoxin comprised of a mesothelin-targeting antibody fragment linked to an engineered cytotoxic domain of Pseudomonas exotoxin A. The majority of mesothelioma patients treated with an earlier version of LMB-100, called SS1P, experienced dose-limiting immune responses despite the use of potent immunosuppressants. However, the few patients tolerating more than one treatment cycle in this trial showed marked antitumor activity in patients with chemotherapy-refractory mesothelioma.

The co-administration of SVP-Rapamycin with LMB-100 in mice models prevented the formation of anti-LMB-100 antibodies and allowed for the administration of at least four treatment cycles, representing a marked increase in the number of effective doses that could be administrated without the onset of neutralizing antibodies. Further, in a tumor model, the addition of SVP-Rapamycin restored the beneficial effect of LMB-100 on controlling tumor growth.

"These pre-clinical proof of concept data clearly demonstrate the potential benefit of co-administrating LMB-100 and SVP-Rapamycin, two products currently used in clinical trials," said Peter Keller, M.Sc., Chief Business Officer at Selecta. "The program is part of our objective to extend our clinical pipeline by applying our SVP technology platform to oncology treatments. In oncology, the effectiveness of many therapies could be enhanced by antigen-specific mitigation of undesired immune responses."

Selecta is developing SVP-Rapamycin for co-administration with biologic therapies for the antigen-specific mitigation of undesired humoral and cellular immune responses. The company is focused on three strategic areas: enzyme therapy, gene therapy and oncology. SVP-Rapamycin has the potential to be co-administered with a multitude of biologic drugs that have been identified in each of these areas to increase the number of treatable patients and/or enhance efficacy and safety.

Selecta’s lead product candidate, SEL-212, applies SVP-Rapamycin to pegsiticase, a pegylated uricase. SEL-212 is designed to be the first non-immunogenic version of uricase, an immunogenic enzyme that targets uric acid. SEL-212 is in a Phase 2 clinical trial and is being developed for patients with chronic refractory and tophaceous gout.

About LMB-100

LMB-100 is a next generation immunotoxin comprised of a mesothelin-targeting antibody fragment linked to an engineered cytotoxic domain of Pseudomonas exotoxin A. Mesothelin, a cell surface antigen discovered in Ira Pastan’s laboratory at NCI, is overexpressed in mesothelioma, pancreatic, ovarian and lung cancers. Dr. Pastan is a world-renowned expert in the design and development of immunotoxins. A first generation mesothelin-targeted immunotoxin, SS1P, could only be given for 1 cycle because it was immunogenic, but showed marked antitumor activity in patients with chemotherapy-refractory mesothelioma, when combined with drugs to suppress the development of anti-drug antibodies. LMB-100 was engineered to reduce immunogenicity and off target toxicity. LMB-100 is currently in phase 1 clinical studies by CCR investigators at the NIH Clinical Center in Bethesda, Maryland.