Today's News

Ra Pharma Aims For Oral Peptide Drugs Using Synthetic Amino Acids / Just out of stealth mode, privately held biotech closes second tranche of $27 million Series A financing and announces first drug program will pursue an oral kallikrein inhibitor for prevention of hereditary angioedema. / “The Pink Sheet”

Business & Finance

Plavix Takes A Final Bow, But Will It Go Gracefully? / Generic versions of Bristol-Myers Squibb/Sanofi’s blockbuster clot-buster clopidogrel launched in the U.S. May 17, but the companies are helping some patients continue on the brand by covering the high out-of-pocket costs. / “The Pink Sheet” May 21, 2012

Post Biocon, Pfizer Pushes Forward On Biosimilar MABs / Biosimilars pioneers face a steep learning curve and multiple surprises, as shown by Pfizer’s recent and expensive backtrack on its deal with India’s Biocon. But Pfizer says the setback has reaffirmed its strategy as it pushes ahead on its own with a monoclonal antibody program, led by a biosimilar rituximab. / “The Pink Sheet” May 21, 2012

Deals of the Week: GSK Working On Three Deals, Agilent/Dako / GlaxoSmithKline tries to turn partnerships into acquisitions with varying results, as one company accepts a buy-out while another adopts a poison-pill strategy. / “The Pink Sheet” May 21, 2012

R & D

R&D For Diseases Of Developing Countries Could Be Driven By Pooled Funds / WHO committee backs use of pooled funds to finance R&D, nixes priority review vouchers and finds no need for data exclusivity. Novartis’ Paul Herrling, a committee member, notes that governments would be responsible for R&D costs. / “The Pink Sheet” May 21, 2012

Novartis Typhoid Vaccine Seeks Partner After Securing Clinical Trial Site / Phase II study is ongoing in Pakistan, a year after Novartis convinced the Pakistani government to lift its ban on clinical trials. Antimalarials with a different mechanism of action than Coartem are in Phase I and II trials. / “The Pink Sheet” May 21, 2012

Bad News/Good News For Cholesterol: Another Strike Against HDL, But Support For Stricter LDL Targets / A large genetic analysis published in the Lancet suggests that drugs that raise HDL may not reduce cardiovascular risk, creating more bad news for a field still reeling from the failure of Roche’s dalcetrapib. But another study calls for much wider use of LDL-lowering drugs, even in patients with low cardiovascular risk. / “The Pink Sheet” May 21, 2012

Regulatory Update

PDUFA V Focus On Speeding FDA Drug Reviews May Be Unfounded, Study Concludes / A New England Journal of Medicine study found that FDA is faster in reviewing novel therapeutics than regulatory agencies in Europe and Canada. / “The Pink Sheet” May 21, 2012

Biosimilar Suffix Naming Idea Trips On Dispensing Problem / American Pharmacists Association tells FDA during biosimilar guidance hearing that using suffixes to create unique names will be problematic. FDA may be leaning toward the unique names, saying published literature indicates adequate safety tracking is not possible without them. / “The Pink Sheet” May 21, 2012

Advisory Committees

Two Indications, One REMS: FDA Panel Debates Restricted Access For Truvada In PrEP / FDA did not ask its Antiviral Drugs Advisory Committee whether Gilead’s proposed REMS for pre-exposure prophylaxis should include restricted distribution, but it still got an earful on the subject from some vocal panel members, who said prescribing should be limited only to individuals with documentation of a negative HIV test. Agency staff, however, said such an approach was impractical due to Truvada’s unrestricted availability for HIV treatment. / “The Pink Sheet” May 21, 2012

Behavioral Considerations Abound In FDA Review Of Truvada For PrEP / The potential dangers associated with medication non-adherence, failure to obtain regular HIV testing and “risk compensation” were cited by critics as reasons not to approve Truvada for pre-exposure prophylaxis. Although Gilead’s proposed REMS targets these behaviors, it remains to be seen whether such risk management efforts will have an impact. / “The Pink Sheet” May 21, 2012

Recent And Upcoming FDA Advisory Committee Meetings / Recent and upcoming FDA advisory committee meetings and a summary of topics covered. / “The Pink Sheet” May 21, 2012

Recent Round Of Obesity Reviews Suggests CV Safety Standards Have Come Into Focus / The advisory committee on Arena Pharmaceuticals’ lorcaserin continues to bring into focus what FDA and its expert advisers expect in terms of cardiovascular safety assessment for weight-loss drugs, possibly signaling a new consensus and the end of years of confusion. / “The Pink Sheet” May 21, 2012

Litigation

Medivation Battles UCLA Over Rights To Prostate Cancer Compound / UCLA researchers secretly developed a compound almost identical to Medivation’s MDV3100 (enzalutamide), a breach of contract suit claims. The company expects to launch MDV3100 later this year. / “The Pink Sheet” May 21, 2012

Medicare

Medicare CED Could Support, Benefit From Surveillance Systems Like FDA’s Sentinel – McClellan / At a May 16 Medicare Evidence Development and Coverage Advisory Committee meeting, former CMS and FDA Chief Mark McClellan advocated salvaging Medicare’s little-used coverage with evidence development policy for medical products. / “The Pink Sheet” May 21, 2012

“Next Phase” For CED Should Focus On Treatments That Lower Cost, MEDCAC Told / The next iteration of CMS’ Medicare coverage with evidence development policy should limit application of the reimbursement tool to treatments that can lower overall health care spending, Center for Medical Technology Policy CEO Sean Tunis told the Medicare advisory committee. / “The Pink Sheet” May 21, 2012

Generic Drugs

FDA’s ANDA Approvals / Generic drug approvals and tentative approvals for mid-May. / “The Pink Sheet” May 21, 2012

Publisher's Spotlight

"Opportunities and Challenges in the Indian Biopharmaceutical Market" Special Report / If you are interested in expanding your healthcare company, India is a market full of potential, both for developing biopharmaceuticals and pharmaceuticals, and for manufacturing them. The competitive market, availability of raw materials, and continually growing local market are all factors that contribute to the great opportunities available in India. / “The Pink Sheet” May 21, 2012