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BIOCENTURY EXTRA LATEST HEADLINES


   TOP STORY

Massachusetts requiring patient history check for Zohydro

Massachusetts Gov. Deval Patrick said doctors are now required to check a patient's controlled substance history through a statewide prescription monitoring program (PMP) prior to prescribing pain drug Zohydro ER hydrocodone bitartrate from Zogenix Inc. (NASDAQ:ZGNX). The program tracks dispensing information on controlled substances scheduled by the U.S. Drug Enforcement Agency as class II though IV scheduled drugs. Zohydro ER -- an oral, non-abuse deterrent extended-release (ER) formulation of hydrocodone -- is a class II scheduled drug. In Massachusetts, a prescription for a class II scheduled drug can only cover a 30-day supply, so prescribers would be required to check a patient's history through the program every 30 days. more >>

   FINANCIAL NEWS

Biogen Idec beats on revenues, misses on EPS

Biogen Idec Inc. (NASDAQ:BIIB) reported 1Q14 non-GAAP diluted EPS of $2.47, up from $1.97 in 1Q13, but below the Street's $2.56 estimate. First quarter revenues were $2.1 billion, up 51% from $1.4 billion in 1Q13 and beating the Street's $2 billion estimate. Biogen Idec said non-GAAP EPS was reduced by about $0.35 as a result of a $118 million R&D expense related to its March Alzheimer's deal with Eisai Co. Ltd. (Tokyo:4523) (see BioCentury, March 24). more >>

Kala raises $22.5 million series B

Kala Pharmaceuticals Inc. (Waltham, Mass.) raised $22.5 million in a series B round led by new investor Ysios Capital. An undisclosed new strategic investor also participated along with existing investors Crown Venture Fund; Lux Capital; Polaris Partners; and Third Rock Ventures. Ysios' Karen Wagner will join Kala's board. more >>

Aerpio raises $18 million in A-2 round

Aerpio Therapeutics Inc. (Cincinnati, Ohio) raised $18 million in a series A-2 round led by new investor OrbiMed. Existing investors Novartis Venture Funds; Satter Investment Management; Kearny Venture Partners; Venture Investors; Triathlon Medical Ventures; and Athenian Venture Partners also participated. OrbiMed's Chau Khuong will join Aerpio's board. more >>

Amgen slides on 1Q14 miss

Amgen Inc. (NASDAQ:AMGN) fell $5.99 to $113.32 on Wednesday after reporting 1Q14 earnings late Tuesday that missed the Street. Adjusted diluted EPS was $1.87 on revenues of $4.5 billion. The Street was expecting EPS of $1.94 on $4.8 billion in revenues. The miss was due in part to lower than expected sales of Enbrel etanercept. The autoimmune drug had 1Q14 sales of $988 million, down 5% over the prior year's quarter and down 18% sequentially due to lower unit demand. According to Deutsche Bank's Robyn Karnauskas, the Street was expecting $1.1 billion in Enbrel sales. Amgen's Wednesday move translates to a $4.5 billion loss in market cap for a closing valuation of $85.7 billion (see BioCentury Extra, April 22). more >>

Quotient amends IPO

Transfusion diagnostics company Quotient Ltd. (Penicuik, U.K.) amended its IPO and now plans to sell 5 million units at $8 on NASDAQ, which would raise $40 million. Each unit comprises a share and a warrant to purchase 0.8 shares, with each whole warrant exercisable through October 2015 at $8.80. Earlier this month, Quotient said it planned to sell 5 million shares at $9-$11; the company would have raised $50 million at the $10 midpoint. UBS; Baird; and Cowen are underwriters. more >>

   CLINICAL NEWS

IV Captisol-enabled Melphalan meets safety endpoint

Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said IV Captisol-enabled Melphalan met the primary safety endpoint in a Phase IIb trial evaluating the product as myeloablative therapy prior to autologous stem cell transplantation (ASCT) in multiple myeloma (MM) patients. Spectrum declined to disclose details. The open-label, U.S. pivotal trial enrolled 60 MM patients. more >>

Prothena jumps on Phase I data for NEOD001

Prothena Corp. plc (NASDAQ:PRTA) jumped as much as $7.59 (22%) on Wednesday before closing the day up $3.21 (10%) to $36.95 on interim data from an ongoing Phase I trial of NEOD001 to treat amyloid light-chain (AL) amyloidosis. Five of nine evaluable patients had undisclosed reductions in levels of N-terminal pro-brain natriuretic peptide (NT-proBNP). Lower levels of that marker indicate increased cardiac function. Three patients had stable levels. Cardiac function is the major determinant of survival for AL amyloidosis patients. more >>

   COMPANY NEWS

FDA approves J&J's siltuximab

FDA approved a BLA for Sylvant siltuximab from Johnson & Johnson (NYSE:JNJ) to treat multicentric Castleman's disease in patients who are HIV-negative and human herpes virus 8 (HHV-8)-negative. The chimeric mAb against IL-6 is the first approved treatment in the U.S. for the disease, a rare blood disorder that affects more than one group of lymph nodes in different anatomical areas. more >>

Mitsubishi Tanabe names new CEO

Mitsubishi Tanabe Pharma Corp. (Tokyo:4508) proposed a number of changes to its executive management and board, including naming Masayuki Mitsuka president, CEO and a director. He would replace Michihiro Tsuchiya, who will become chairman. Mitsuka is senior managing executive officer of management strategy and corporate management at Mitsubishi. The changes will be voted on at the company's annual shareholder meeting on June 20. more >>

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BIOCENTURY, THE BERNSTEIN REPORT ON BIOBUSINESS

BIOCENTURY, THE BERNSTEIN REPORT ON BIOBUSINESS
COVER STORY

ASCO's honest broker

ASCO is developing an initiative to facilitate off-label access to targeted cancer therapies. If successful, the system could serve as a model for third-party bodies that could manage early access to experimental therapies.

PRODUCT DISCOVERY & DEVELOPMENT

CAR hits pothole

Adverse events led to protocol revisions in Sloan Kettering's trial of CD19-targeted CAR T cells. But partner Juno Therapeutics and other CAR players don't think this indicates a class effect.

EMERGING COMPANY PROFILE

Minoryx: Mediating rare metabolism

Minoryx both identifies novel chaperones and repurposes drugs to treat inherited metabolic diseases.

True North: Dynamiting complement

True North's TNT009 inhibits an upstream target in the classical complement pathway that could lead to greater efficacy and an improved safety profile relative to other complement inhibitors.

REGULATION

Pain politics

FDA Commissioner Margaret Hamburg responds to critics of the agency's decision to approve Zogenix's Zohydro and warns about consequences for the integrity of science-based regulation.

FINANCE

Wait for it

Foundation, Karyopharm not alone as biotechs hold off double-dipping the market

Bad beat

Investors' CHF61 million gamble on Cytos' asthma program falls flat

Undiluted injection

Why Kaleo did royalty deal to back launch of Evzio for opioid overdose

European beachhead

Epirus thinks reverse merger with Zalicus will open up Europe for biosimilars

Morgan Stanley to Juno

Why Steve Harr left Morgan Stanley for cancer immunotherapy play Juno

Analyst tracks

Biotech investor, banker and analyst personnel changes

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