11/28/2012

CoreRx & ViroPro Announce Agreement

CoreRx, Inc. and Viropro, Inc. recently announced the two companies have entered into a Reciprocal Referral Agreement. The Agreement will benefit both companies’ existing and potential clients with diverse product pipelines by combining CoreRx’s problem-solving and formulation/processing expertise in small molecules with Viropro’s reputation in the development and manufacturing of biopharmaceutical drugs.

“The agreement is another important step in Viropro’s push to build a global network committed to delivering solutions to advance new medicines. It will also leverage Viropro’s expertise to provide clients with optimized solutions to their biopharmaceutical development challenges,” said Cynthia Tsai, Chairperson and Interim CEO of Viropro, Inc.

“We are pleased we are going to continue to improve upon the technologies we are able to offer our clients,” added Todd R. Daviau, CEO of CoreRx. “Since our inception, CoreRx has been working to meet the challenges of drug delivery and enhance the performance of our clients’ drugs. By addressing the needs of clients in biosimilar and large molecule development, CoreRx will continue to play a role in the development of drug candidates and the diversification of their pipelines.”

Viropro specializes in the development and manufacturing of biopharmaceutical drugs. It offers services to a wide array of pharmaceutical and biotechnology companies, and conducts operations through its subsidiaries, Viropro International Inc. (Montreal, Canada), Biologics Process Development (Poway, CA), and Alpha Biologics (Penang, Malaysia). For more information, visit www.viropro.com.

CoreRx is a contract research organization providing customized preformulation services, formulation development, manufacturing, and analytical services to pharmaceutical, biotechnology, academic, and veterinary clients. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. For more information, visit www.corerxpharma.com.

XOMA Corporation Seeks to Sublicense Drug

XOMA Corporation recently announced the 837-patient Phase III PATH trial (Perindopril Amlodipine for the Treatment of Hypertension) has demonstrated the fixed-dose combination (FDC) of perindopril arginine combined with amlodipine besylate is statistically significantly superior to either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after 6 weeks of treatment. This FDC, containing a patent-protected proprietary form of perindopril, was licensed by XOMA as part of a US commercial and development rights agreement signed with Servier for its perindopril franchise. Servier markets the fixed-dose combination product, COVERAM, in 91 countries outside the US.

“The perindopril/amlodipine FDC is an important asset in Servier’s cardiovascular franchise. We believe that based upon our previous conversations with the FDA, the positive PATH results combined with the body of existing clinical data for this FDC will support an NDA submission,” said John Varian, Chief Executive Officer of XOMA. “We are extremely proud of our team for completing this trial ahead of schedule and now will be working to identify appropriate potential ways to move this FDC forward to the US market. XOMA does not intend to directly market this FDC, but rather intends to sublicense this product to a third-party organization that is dedicated to commercializing products for the cardiovascular marketplace.”

The FDC appeared to be well tolerated in the trial, and there were no unexpected serious adverse events reported. The most common adverse events included mild-to-moderate edema, cough, and headache, which are known side effects of the individual components of the FDC.

Perindopril, an angiotensin-converting enzyme inhibitor (commonly called an ACE inhibitor), has been studied in seven landmark clinical trials involving more than 54,000 patients. This body of clinical evidence supports its beneficial impact in treating essential hypertension and stable coronary artery disease. Amlodipine, a calcium channel blocker (commonly called a CCB), is the most-prescribed antihypertensive in the US. Because ACE inhibitors and CCBs target different cardiovascular functions, physicians often use them in combination to treat their hypertensive patients.

In January 2012, XOMA acquired US rights to the perindopril franchise from Les Laboratoires Servier, XOMA’s partner for its lead antibody product candidate, gevokizumab (formerly XOMA 052). The agreement includes the angiotensin-converting enzyme (ACE) inhibitor perindopril, currently marketed under the trade name of ACEON, and a portfolio of three fixed-dose combination product candidates in which perindopril is combined with other active ingredient(s). The proprietary form of perindopril in each of the combination product candidates provides patent protection until 2023. The first product candidate XOMA elected to develop is a fixed-dose combination of perindopril arginine and amlodipine besylate.

ACEON is indicated for the treatment of patients with essential hypertension. ACEON may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. In clinical studies, the most common adverse events (incidence greater than or equal to 5%) were cough, dizziness, and back pain.

ACEON is indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. ACEON can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive, or lipid-lowering therapy. In clinical studies, the most common adverse events leading to discontinuation were cough, drug intolerance, and hypotension. Perindopril erbumine has been available as a generic product in the U.S. since November 2009.

XOMA combines a portfolio of innovative therapeutic antibodies, both in late-stage clinical development and in preclinical research, with its recently launched commercial operations. XOMA focuses its antibody research and development on allosteric modulation, which offers opportunities for new classes of therapeutic antibodies to treat a wide range of human diseases. For more information, visit www.xoma.com.

MethylGene Closes Substantial Private Placement

MethylGene Inc. recently announced it has completed its previously announced private placement of 179,690,970 units at a subscription price per unit of Cdn.$0.145 (the Subscription Price), each unit consisting of one common share and thirty one-hundredths (0.30) of a common share purchase warrant, exercisable until November 19, 2017, at an exercise price of Cdn.$0.174 (being 120% of the Subscription Price), for gross proceeds to MethylGene of approximately Cdn.$26.1 million.

The lead investor in the Offering was Tavistock Life Sciences, an insider of the Company, and other insiders participating in the Offering included funds managed by Baker Bros. Advisors, LLC, a fund managed by OrbiMed Advisors LLC, and Tang Capital Partners, LP. Other investors participating in the Offering included RA Capital Management and BVF Partners L.P.

“This funding represents the continuing commitment of our existing shareholders as well as a broadening of our shareholder base,” said Dr. Charles Baum, President and Chief Executive Officer. “The net proceeds from the Offering will enable us to reach significant milestones in our two lead programs, MGCD265 and MGCD290, in 2013 and 2014.”

MGCD265, a multi-targeted receptor kinase inhibitor for oncology, continues to progress and is expected to advance into multiple Phase I/II expansion cohorts upon reaching the Maximum Tolerated Dose (MTD). Indications of interest include renal cell, gastric, hepatocellular, and non-small cell lung (NSCLC) cancers that express the c-Met target. Plans are underway to incorporate the novel target, Axl, into future studies. Axl is elevated in a number of cancer types, including NSCLC, where it is thought to play a role in resistance to EGFR inhibitors. Planning has also commenced for later-stage randomized trials to evaluate MGCD265 in gastroesophageal cancer or NSCLC patients whose tumors express the c-Met target. Additional pilot studies may also be initiated in selected patient populations.

MGCD290, a novel antifungal agent targeting the fungal Hos2 enzyme, will complete enrollment in a randomized, double-blind, placebo-controlled Phase II study in patients with moderate-to-severe vulvovaginal candidiasis (VVC) this quarter, and topline results from this trial will be reported in the first quarter of 2013. Planning is underway for continued development of this agent in VVC, and for expanded development in additional indications including systemic candidiasis.

With the proceeds from the Offering, and based on its current clinical development and operating plans, the Company’s cash runway is expected to extend into the second half of 2014. Jefferies & Company, Inc. and MTS Securities, LLC acted as financial advisors to MethylGene for the Offering in the United States.

MGCD265 is a rationally designed, orally administered small molecule kinase inhibitor that targets the receptor tyrosine kinases (RTKs) Met, VEGFR 1,2,3 and Axl, as well as Tie2 and Ron. RTKs are key kinases involved in cancer, angiogenesis (a process whereby new blood vessels are formed to nourish the tumors), tumor cell metastasis, tumor development, and survival. Met expression is elevated and associated with tumorigenesis in several solid tumor indications, including NSCLC, gastric, prostate, colorectal, bladder, breast, renal, hepatocellular, and ovarian cancers. Phase I/II studies of single agent MGCD265 and combinations with erlotinib or docetaxel are currently underway. More than 200 patients have been treated to date in clinical studies of both single-agent and combination therapy with docetaxel or erlotinib.

MGCD290 is a first-in-class, orally available, small molecule inhibitor of the fungal enzyme Hos2. In preclinical models, the combination with azole antifungal agents results in broader coverage of fungal pathogens and decreases resistance to the most widely used antifungal agents. MGCD290 is being developed as a combination product with fluconazole, the most widely used triazole antifungal. In vitro, MGCD290 in combination with fluconazole reverses fluconazole resistance (primary and acquired) in a wide range of fungal species, including Candida glabrata. MGCD290 has completed multiple Phase I studies in healthy adult volunteers and has shown an excellent safety profile without drug-drug interactions in combination with fluconazole. A randomized, controlled Phase II study in moderate-to-severe VVC is underway.

MethylGene Inc. (MYG.TO) is a drug development company that is advancing novel therapeutics for cancer and infectious disease in human clinical trials. MethylGene owns all rights to its aforementioned lead product candidates, and has partnerships with Otsuka Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., and EnVivo Pharmaceuticals, Inc. for its other pipeline programs. For more information, visit www.methylgene.com.

BASF Plans to Acquire Pronova BioPharma

BASF recently announced it plans to acquire Pronova BioPharma ASA, Lysaker, Norway, a pioneer in the field of research, development, and manufacturing of omega-3 fatty acids. BASF has reached an agreement with Pronova to make a recommended voluntary public takeover offer to Pronova’s shareholders, and will offer to pay NOK $12.50 in cash for each Pronova share. The Board of Directors of Pronova and the management unanimously support BASF’s offer and recommend its acceptance.

In addition, BASF has obtained irrevocable pre-acceptance commitments for approximately 60% of Pronova’s share capital; including the 50% stake held by majority shareholders Herkules Private Equity Fund (held through its funds Herkules Private Equity (Jersey-I) L.P. and Herkules Private Equity (Jersey-II) L.P.), an approximately 9.1% stake indirectly controlled by investment firms Kistefos AS and Kistefos Investment AS and 0.3% held by members of the Board of Directors and management of Pronova.

The offer corresponds to a premium of 24% above the volume-weighted average share price for Pronova’s shares in the 6 months prior to announcement of the public takeover offer. Based on all outstanding shares and including all net financial liabilities, the enterprise value would be more than $860 million.

“The intended acquisition will significantly strengthen our position in the fast-growing and highly profitable market for omega-3 fatty acids. We want to combine the global market reach and experience of BASF with the know-how of Pronova in omega-3 fatty acids,” said Michael Heinz, Member of the Board of Executive Directors of BASF SE and responsible for the Performance Products segment, which includes the Nutrition & Health division.

Highly concentrated omega-3 fatty acids are a globally growing market, driven by an increasing consumer awareness of omega-3 fatty acids health benefits. With the acquisition of Pronova, BASF will immediately achieve a leading position in the global market for omega-3 fatty acids. Pronova’s active pharmaceutical ingredients are used to treat cardiovascular diseases such as post-myocardial infarction. In nutritional applications, including dietary supplements, there is a strong body of evidence supporting a broad range of positive health benefits through omega-3 fatty acids, for example, in the areas of cognitive development or heart health.

The acquisition will be financed by way of available resources of BASF. The offer will be made by BASF’s wholly owned subsidiary BASF AS in Norway and will be subject to certain conditions, including inter alia that shareholders shall in the aggregate have accepted the offer for a number of shares representing more than 90% of the total share capital of Pronova, and the same amount of votes, which can be exercised in the general meeting of Pronova and that there shall have been no occurrence of a material adverse change. The offer will also be subject to approval by the relevant merger control authorities. The complete details of the offer, including all terms and conditions, will be included in an offer document complying with the requirements of the Norwegian Securities Trading Act, which is expected to be sent to Pronova’s shareholders on or about December 5, 2012. BASF expects to finalize the transaction in the first quarter of 2013.

BASF is the world’s leading chemical company: The Chemical Company. Its portfolio ranges from chemicals, plastics, performance products, and crop protection products to oil and gas. For more information, visit www.basf.com

Genzyme Corporation Announces Drug Approval

Genzyme, a Sanofi company, recently announced that the Australian Therapeutic Goods Administration (TGA) has approved AUBAGIO (teriflunomide) 14 mg as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). The TGA approval will enable health professionals to prescribe AUBAGIO 14 mg in Australia, which is now the second country to gain marketing authorization for the treatment, following FDA approval in September.

“We are very pleased with the TGA approval of AUBAGIO that makes available a new option for healthcare professionals, and people living with MS in Australia who may benefit from this once-daily, oral treatment,” said Bill Sibold, Head of Multiple Sclerosis, Genzyme. “The availability of AUBAGIO in the US and subsequent registration in Australia not only demonstrates our continued progress, it also reflects our commitment to deliver differentiated treatments and provide access for patients globally.”

The TGA’s approval of AUBAGIO was based on safety and efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. The ongoing AUBAGIO clinical development program, involving more than 5,000 patients in 36 countries, including Australia, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years.

“For some people living with MS, the additional burden of injectable therapies administered daily to weekly can sometimes be a struggle,” said Associate Professor John King, Senior Neurologist, Royal Melbourne Hospital, who participated in the clinical trials for AUBAGIO. “It is exciting to see a new oral treatment that has been shown to both reduce relapses and slow the progression of disability. This is an encouraging development for the MS community.”

AUBAGIO is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for AUBAGIO is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).

“We welcome the advent of a new oral treatment option for MS patients in Australia,” said Professor Bill Carroll, Chairman of MS Research Australia. “It is important for people with MS and their clinicians to have access to a range of well-tolerated and convenient therapies that may reduce the impact of the disease on their lives and suit their lifestyle.”

AUBAGIO is marketed in the US and now Australia. Marketing applications for AUBAGIO are under review by the European Medicines Agency (EMA) and other regulatory authorities.

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. It accomplishes its goals through world-class research and with the compassion and commitment of its employees. For more information, visit www.genzyme.com.

Teva to Focus on Smaller M&A

Teva Pharmaceutical Industries Ltd. is shifting away from the multi-billion dollar acquisitions that have defined its growth for the past decade, indicating acquisitions don’t have to be major to be important,” said Chairman Phillip Frost, who owns about $815 million of Teva shares, in an interview on November 19 in his Miami office. “The idea of the multibillion-dollar type of acquisition is going to be reserved for very special cases going forward, in which the desirability is so compelling and so game-changing that everyone will feel it has to be done.”

Mr. Frost’s comments signal the world’s biggest generic drugmaker may be shying from a strategy that saw it buy Frazer, Pennsylvania-based Cephalon Inc. for $6.2 billion, and Ratiopharm GmbH, based in Ulm, Germany, in a $4.9-billion deal. Petach Tikva, Israel-based Teva has made 25 buy-outs in the past 10 years, including five valued at $3 billion or more, according to data compiled by Bloomberg.

The company’s Israeli shares gained 1.6% to 155.60 shekels, the equivalent of $39.84, in Tel Aviv. The benchmark TA-25 index rose 0.3% to 1,208.66. Teva’s New York shares climbed 1.8% recently, leading gains in the Bloomberg Israel-US Equity Index of the largest Israeli companies traded in New York.

“There is the opportunity for product acquisitions, for small company acquisitions, for technology acquisitions, and to bring in new people who themselves are capable of creating the new products,” explained Mr. Frost.

Teva’s board tapped earlier this year Jeremy Levin, a former Senior Vice President for Strategy at Bristol-Myers Squibb Co., to become the Chief Executive Officer of the world’s largest maker of generic medicines, as it seeks to diversify in branded drugs. The CEO, who joined the company in May, plans to give investors a strategy update, dubbed “Project Spring,” on December 11 in New York.

American depositary receipts of the Petach Tikva, Israel-based company have dropped 2.2% this year, lagging behind the 8.3% rally for the MSCI World Pharmaceutical Index (MXWD0PH), as investors remain skeptical the company can sustain growth for its branded multiple-sclerosis drug Copaxone. Teva’s ADRs trade at 7.3 times estimated earnings, the lowest valuation among the world’s 20 biggest drug companies, which have an average price-earnings ratio of 13.4.

Teva’s stock is undervalued, and investors will realize that as Mr. Levin implements a new strategy, said Mr. Frost, who became a Teva shareholder when he sold his generic-drug maker Ivax Corp. to Teva for $7.6 billion in 2006.

“On the novel product side, Jeremy brings experience to the table that we didn’t really have at Teva before,” he said. Mr. Levin and Michael Hayden, Teva’s new Chief Scientific Officer, “will have their influence permeate the company so that the mindset will over time shift from being a generic company to a more broadly based pharmaceutical business,” said Mr. Frost. “Copaxone sales will hold up.”

The drug, an injection that accounts for about 40% of US sales of MS treatments, faces new competition from Novartis AG oral drug Gilenya. US regulators are reviewing another MS pill, Biogen Idec Inc. BG-12. Generic-drug makers are also appealing a court decision that upheld Copaxone’s US patents through 2015.

“Copaxone will be around for quite a while, I’m sure of it,” stressed Mr. Frost. “At a certain point, it’s possible a generic will affect certain markets, but the product itself will continue to be important in other markets.”

The US court decision may give Teva more time to switch patients to a new, higher-dose version of the drug. Teva has said that a late-stage trial of a longer-acting formulation reduced MS relapses more than a placebo and showed a “favorable” safety profile. Teva is also considering an entrance into emerging markets from Brazil to China, where the company’s presence is relatively smaller, said Mr. Frost.

“There is room for a lot of creativity at this point,” said Mr. Frost. “The creativity will go along with experience.”

To contact the reporter on this story: David Wainer in Tel Aviv at dwainer3@bloomberg.net. To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net.