"The Pink Sheet" DAILY :: Elsevier Business Intelligence

Solomon To Step Aside As Forest Exec; Icahn Wins Another Victory

Stacy.Lawrence@elsevier.com — Thu, 23 May 2013 18:33:47 -0400

President and CEO of Forest Laboratories Howard Solomon will retire at the end of the year. Activist investor Carl Icahn has long inveighed against the 85 year-old exec.

BTG Makes Two Buys To Build Interventional Medicine Business

s.stovall@elsevier.com — Thu, 23 May 2013 16:13:05 -0400

BTG of Britain plans two new acquisitions, including a therapy for liver cancer that uses radioactive glass beads and a treatment for dissolving severe blood clots. The deals create an interventional medicine business with potential sales of $1 billion; BTG is funding much of the exercise through a share placement.

FDA’s Root Cause Investigation Into Bupropion Trouble Could Have Broad Implications For Generics

s.karlin@elsevier.com — Thu, 23 May 2013 14:00:00 -0400

Agency is now turning to outside researchers for studies to determine why Impax and Teva’s 300 mg bupropion generic failed and what that might mean for generics as a whole.

Suvorexant’s “Twilight Zone”: Advisory Panel, FDA Favor Low Dose; Merck Does Not

s.karlin@elsevier.com — Wed, 22 May 2013 23:48:12 -0400

FDA and its advisors seem to support lowering the proposed dose for Merck insomnia treatment suvorexant as a way to save the marketing application, but Merck appears insistent that the lower 10 mg dose doesn’t work.

Stand-Alone Part D Plans Subject To Medical Loss Ratio Checks, CMS Confirms

c.kelly@elsevier.com — Wed, 22 May 2013 19:11:09 -0400

Drug firms and insurers are concerned that the standards may put too much pressure on Medicare prescription drug plans and jeopardize the ability of some plans to continue operating.

Ahead Of Schedule, Pfizer Prepares To Set Zoetis Free In Stock Swap

l.lamotta@elsevier.com — Wed, 22 May 2013 19:08:04 -0400

The Big Pharma intends to loosen its leash on its former animal health business come June when Pfizer shareholders will be given an option to swap their shares for Zoetis stock. Meanwhile, Pfizer continues its strategy to shift its focus back to the core pharmaceutical business.

NICE Rejects Avastin For Ovarian Cancer On Cost, Okays Lucentis

Wed, 22 May 2013 18:37:22 -0400

NICE has knocked back Avastin for ovarian cancer due to high cost, but Roche may have a plausible market strategy in place for the drug in the UK.

Compounding Bill Glides Toward Senate Floor; FDA Gets More Flexibility On Fees

d.gingery@elsevier.com — Wed, 22 May 2013 17:18:13 -0400

Senate HELP Committee attaches amended compounding bill to track-and-trace legislation as Sen. Isakson lists three remaining concerns.

Rx Supply Chain Bill On Track In Senate; Will House Use The Same Gauges?

c.dombrowski@elsevier.com — Wed, 22 May 2013 17:15:00 -0400

Track-and-trace measure goes to floor coupled to compounding bill, but the all-smiles markup in the Senate HELP Committee is more than made up for by the differences that remain with the House version.

Mylan: Brand/Generic Distinction Disintegration Is Necessary

j.haas@elsevier.com — Wed, 22 May 2013 16:33:17 -0400

Consolidation in the generic industry is good and necessary, Mylan CEO Heather Bresch said during a recent investor presentation. Mylan is well-positioned in the changing market, she said, thanks to business development such as its biosimilars agreements with Biocon and its Japan collaboration with Pfizer.

Pfizer Guards Viagra Sales, Moves Against Tainted Supplements

e.crawford@elsevier.com — Wed, 22 May 2013 14:00:00 -0400

A Pfizer study that finds 81% of sexual performance products claiming to be natural have undeclared pharmaceuticals could pressure FDA to increase enforcement and Congress to boost funding for the effort. The firm also launches online sales of Viagra to combat sales of counterfeit erectile dysfunction drugs.

A Trio Of Strategic VCs Helps To Back Effector Therapeutics With $45 Million

p.bonanos@elsevier.com — Tue, 21 May 2013 18:03:57 -0400

Using technology spun out of UCSF, a new company hopes to develop oncology drugs that target effector mechanisms of protein synthesis, thereby affecting multiple oncogenes simultaneously. The San Diego-based biotech also hopes to license out its platform for non-cancer indications, bringing in non-dilutive money.

Everything REMS Under The Sun: FDA Lays Out Ambitious PDUFA V Meeting Agenda

s.karlin@elsevier.com — Tue, 21 May 2013 17:52:51 -0400

The struggles that industry and FDA face when trying to best standardize and evaluate REMS are illustrated by the dozens of topics jammed into the two-day meeting.

Karyopharm Scores $48M Series B To Advance Early Cancer Compounds

l.lamotta@elsevier.com — Tue, 21 May 2013 16:46:20 -0400

The Massachusetts biotech has remained well-funded despite shying away from venture capital investors and seeking funds from private investors.

Drug Development Needs “Clean-Slate Think” To Involve Patients All Along The Way – Pfizer’s Lewis-Hall

g.twachtman@elsevier.com — Tue, 21 May 2013 16:19:00 -0400

Drug companies and other stakeholders should collaborate on developing a “clear framework” for patient engagement, Freda Lewis-Hall says at ISPOR.

Norway’s Xellia Pharma Acquired By Novo A/S In $700 Million Buyout

j.davis@elsevier.com — Tue, 21 May 2013 14:50:48 -0400

3i sells Nordic antibacterial manufacturer Xellia Pharmaceuticals, which has plans to develop novel antibiotics, new formulations and new bulk generics.

As India Finalizes New Pricing Policy, Analysts Focus On Potential Winners And Losers

v.dandekar@elsevier.com — Tue, 21 May 2013 14:00:00 -0400

With a new market-based policy in place, prices of leading brands will fall in the short term but losses may be mitigated by tiered pricing and better patient engagement in the long run.

MedWatch’s Patient-friendly Reporting Form Might Need An Overhaul

Tue, 21 May 2013 12:55:53 -0400

Promotion of the consumer MedWatch form needs to be improved if more physicians and consumers are to use it, FDA’s Risk Communications Advisory Committee says.

FDA’s Social Media Messages Should Be Pretested, Risk Communication Advisors Say

s.karlin@elsevier.com — Tue, 21 May 2013 12:44:05 -0400

Risk Communication Advisory Committee members express support for FDA’s social media plans, but emphasize the importance of pretesting messages and studying the impact of agency efforts.

How Low Does Merck Need To Go? FDA Safety Concerns May Cut Suvorexant’s Dosing

s.karlin@elsevier.com — Mon, 20 May 2013 23:42:46 -0400

FDA will ask an advisory committee whether Merck’s insomnia drug should employ the tiered dosing schedule proposed for the elderly and non-responders, but the agency seems inclined towards a dose even lower that the ones that were used in Phase III.

Elan Tries To Transform With Three New Deals; Wall Street Still Skeptical

Stacy.Lawrence@elsevier.com — Mon, 20 May 2013 21:28:56 -0400

In its continuing effort to spend its way into becoming a diversified pharma, Elan announced a new trio of deals. Some liken its geographically diverse, specialty pharma strategy to that of highly successful Valeant, but Wall Street remains unsure that Elan can execute.

Merger With Warner Chilcott Expected To Turn Actavis Into #3 Specialty Pharma In U.S.

j.haas@elsevier.com — Mon, 20 May 2013 18:16:03 -0400

The rumored combination of Actavis and Warner Chilcott, with Actavis to re-domicile as an Irish firm for tax benefits, came to fruition May 20. Warner Chilcott CEO Boissonneault said the deal resulted from a long friendship with Actavis’ Bisaro and did not come together overnight.

Germany’s G-BA Finds No Added Benefit For CTI’s Pixuvri, Exposing Price

f.kermani@elsevier.com — Mon, 20 May 2013 16:54:00 -0400

Germany’s G-BA lets through Cell Therapeutics’ Pixuvri for aggressive B-cell non-Hodgkin's lymphoma but finds no added benefit over existing therapies, meaning its price could come under pressure.

Depo-Provera Black Box Warning Challenged In Physician Petition

b.sandburg@elsevier.com — Mon, 20 May 2013 14:30:00 -0400

Two obstetrician/gynecologists argue there is no published clinical evidence that extended use of the injectable contraceptive is harmful; they cite a Pfizer-funded study that found Depo-Provera users already had a higher risk of bone fracture than nonusers and the risk did not increase with use of the drug.

CardioFocus Piles Up Data On HeartLight Laser AF Ablation Catheter

re.miller@elsevier.com — Mon, 20 May 2013 14:00:00 -0400

In addition to the more than 1,300 ablation procedures completed outside the U.S. with the unique visually guided ablation catheter, the venture-backed company is conducting an IDE trial in 21 U.S. centers, which it expects to complete in 2014.

Roche Teams With QB3 To Incubate Life-Science Start-Ups In Bay Area

j.haas@elsevier.com — Fri, 17 May 2013 17:35:31 -0400

The pharma and the incubator’s venture arm will provide seed funding for start-ups emerging from their collaborative efforts. Later, Roche may participate in Series A funding or even opt in to buy programs or whole companies.

Patent “Silent Disclaimers” Established Under Rituxan Ruling, Biogen Worries

b.sandburg@elsevier.com — Fri, 17 May 2013 17:07:35 -0400

Biogen Idec and Genentech petition the Federal Circuit to rehear en banc a ruling that Biogen’s Rituxan patent claim does not cover GlaxoSmithKline’s Arzerra; they say that failing to expressly object to an examiner’s views does not imply they disavowed the scope of a patent claim.

Financings Of The Fortnight: Bluebird IPO Could Provide Validation For Gene Therapy As A Modality

Fri, 17 May 2013 16:32:59 -0400

During a year in which biotech IPOs have taken off, the bluebird bio issue calls for special attention. Plus news on recent financings by Quintiles, Portola, Isis and Lumena.

Glaxo Uses Contests To Target Young Hopefuls And Academic Minds

s.stovall@elsevier.com — Fri, 17 May 2013 15:45:03 -0400

With a view to front-loading GlaxoSmithKline’s pipeline, the drug maker’s venture capital arm SR One is increasingly targeting early prospects – to the point of running intense entrepreneurial competitions to fan the flames of innovation in Europe and tap into early startups there.

Europe’s VC Retreat May Threaten Drug Innovation There

j.davis@elsevier.com — Fri, 17 May 2013 14:30:02 -0400

The number of VC firms actively investing in European biotech and life science companies - and the funds available for investing - could fall below the critical mass considered vital for supporting innovation, investors warn.

German State Court Ruling Against Novartis Confirms Legality of HTA For Older Products

f.kermani@elsevier.com — Fri, 17 May 2013 14:00:00 -0400

A State Social Court of Berlin-Brandenburg ruling against Novartis means that Germany's reimbursement bodies can move forward with the benefit assessment of older pharmaceutical products.

Another Ranbaxy Mystery: What Happened To Valsartan?

v.dandekar@elsevier.com — Fri, 17 May 2013 14:00:00 -0400

Ranbaxy’s valsartan application may have been held back after FDA detected lapses at the company’s new manufacturing site in Mohali, India, according to sources, but the beleaguered company has a plan to move forward.

Ambit IPO Ambles Out; Portola And Bluebird Prepare

Stacy.Lawrence@elsevier.com — Thu, 16 May 2013 23:46:08 -0400

Despite pricing well below its range and trading down, Ambit could raise $90 million in an IPO and a private placement with existing investors. Also this week, gene therapy company bluebird bio filed for an IPO, and hematology play Portola made the rounds on its investor road show.

FDA Approves Simponi For Ulcerative Colitis

p.bonanos@elsevier.com — Thu, 16 May 2013 19:09:32 -0400

J&J received approval to market a second TNF inhibitor to treat the bowel disorder. The authorization comes as Simponi’s increasing sales point toward blockbuster status.

NICE Lets Astellas Pharma’s Betmiga Pass, But On A Restricted Indication

f.kermani@elsevier.com — Thu, 16 May 2013 19:01:00 -0400

NICE gives the nod to Astellas Pharma’s Betmiga for overactive bladder control due to its cost-effectiveness but nevertheless restricts its indication because it’s not superior to existing therapies.

Large Compounders’ Reporting Requirements Would Move Closer To Manufacturers’ In Senate Bill

d.gingery@elsevier.com — Thu, 16 May 2013 18:27:37 -0400

Compounding manufacturers would have to report adverse events and quality problems much like traditional drug and biologic makers as a Senate committee moves toward mark up of legislation.

Lilly Bracing For Possible Medicare Non-Coverage Or CED Decision On Amyvid

c.kelly@elsevier.com — Thu, 16 May 2013 18:19:26 -0400

Lilly executives discuss likely outcomes of a pending CMS draft decision on Medicare coverage for the beta amyloid imaging agent Amyvid, emphasizing that a decision for non-coverage or coverage with evidence development would be a major setback for research and development in Alzheimer’s disease.

New Nimodipine Formulation Aimed At Reducing Fatal Medication Errors

s.karlin@elsevier.com — Thu, 16 May 2013 17:20:38 -0400

Nymalize, an oral formulation of brain hemorrhage treatment nimodipine, aims to minimize serious risks associated with incorrect administration of older forms of the drug.

“Systemic” Disregard For Basic Dietary Ingredient Rule Troubles FDA

l.gillespie@elsevier.com — Thu, 16 May 2013 14:00:00 -0400

FDA dietary supplement program chief Daniel Fabricant surveyed the agency’s top and developing concerns at the SupplySide MarketPlace conference. DMAA and adulterated products reflect a flouting of the principle that only dietary ingredients should occur in supplements, he says.

Amgen, Novartis Are Investors In Atlas Venture’s Ninth Fund

p.bonanos@elsevier.com — Thu, 16 May 2013 00:01:00 -0400

Atlas pledges to explore areas of mutual interest to the firm and its new corporate limited partners, but the drug firms won’t receive exclusive rights to anything in the new fund’s portfolio.

ASCO Preview: Bristol PD-1 Data Spur Hopes For Double Immunotherapy

e.hayes@elsevier.com — Wed, 15 May 2013 23:35:40 -0400

Immune checkpoint antibodies feature prominently in American Society of Clinical Oncology annual meeting program, showing promise in a range of cancers. Bristol showcases data for Yervoy in combination with its anti-PD-1 nivolumab in melanoma, while Roche unveils extensive early results for its anti-PD-L1 MPDL3280A.

House Track-And-Trace Bill Moves Out Of Committee But No Closer To Senate On Unit-Level Tracing

c.dombrowski@elsevier.com — Wed, 15 May 2013 20:18:28 -0400

Energy and Commerce Committee rejects Rep. Pallone’s amendment to mandate an implementation date for unit-level tracking.

New Drug Payment/Delivery Models Sought For CMS Innovation Grants

s.steinke@elsevier.com — Wed, 15 May 2013 17:45:13 -0400

“High-cost physician-administered drugs” are listed among the priority areas for models to reduce outpatient costs. CMS seeks proposals to test new models for Medicare, Medicaid, and the Children’s Health Insurance Program.

Broader Indications For Tarceva As Astellas Scales Back In The U.S.

l.lamotta@elsevier.com — Wed, 15 May 2013 17:40:09 -0400

The Japanese pharma is consolidating its U.S. operations, including the shuttering of OSI, where Tarceva initially was developed, as the cancer drug gains another indication with a companion diagnostic.

Bayer/Algeta’s Xofigo Brings New Mechanism To Prostate Cancer Field

j.merrill@elsevier.com — Wed, 15 May 2013 17:27:58 -0400

FDA approved the first alpha particle-emitting radioactive therapeutic agent, Bayer/Algeta’s Xofigo (radium Ra 223 dichloride), for prostate cancer patients with symptomatic bone metastases, three months ahead of the expected PDUFA date.

Part D Preferred Pharmacy Networks Need More CMS Oversight, Senators Say

c.kelly@elsevier.com — Wed, 15 May 2013 17:00:19 -0400

The bipartisan group of senators asks the agency to detail steps designed to ensure that Part D plans with preferred networks are not increasing costs to Medicare or impeding beneficiary access to drugs.

FDA’s Potential Black Hole: House Investigates Departure Of Acting Head Of Medical Products Office

d.gingery@elsevier.com — Tue, 14 May 2013 23:15:15 -0400

Energy and Commerce Committee letter states public information discrepancies raised questions about Leona Brenner-Gati’s status and “the circumstances surrounding her resignation.”

HIV Drug Development Challenge: Will Patients Accept Risk Of Cure?

s.karlin@elsevier.com — Tue, 14 May 2013 22:43:39 -0400

The second of FDA’s 20 patient-focused drug development meetings will tackle barriers to patient enrollment in HIV cure studies and current gaps in HIV therapy.

J&J Hoping To Position Simeprevir As Top Next-Gen Protease Inhibitor For HCV

j.haas@elsevier.com — Tue, 14 May 2013 22:02:07 -0400

The pharma’s Janssen Research & Development unit has filed protease inhibitor simeprevir for approval in the U.S., Europe and Japan, recently receiving notification of priority review from FDA; meanwhile, the company waits to see if its compound will be used in combination with Bristol’s daclatasvir or Gilead’s sofosbuvir.

Alvine Hopes To Bring The First Celiac Drug To Market With New Partner AbbVie

l.lamotta@elsevier.com — Tue, 14 May 2013 18:03:33 -0400

Alvine and AbbVie have inked a deal that could allow the larger company to acquire the biotech based on results of a Phase IIb trial for its celiac disease treatment.