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.
Other requirements are in line with the classwide REMS for extended-release and long-acting opioids, which covers Zohydro ER. Neither the company nor Patrick's office responded to questions about whether the state's requirements would create duplicate paperwork. FDA could not be reached for comment.
Last month, Patrick declared opiate addiction a public health emergency, and Massachusetts authorities moved to impose a statewide ban on the prescription or sale of Zohydro ER. Zogenix filed suit challenging the ban. Earlier this month, a judge in the U.S. District Court for the District of Massachusetts granted a temporary injunction requiring that Zohydro ER be available in the state while the suit is ongoing. There are no scheduled hearings on the docket for the suit. Massachusetts has until May 9 to file a response to the injunction.
FDA Commissioner Margaret Hamburg addressed Massachusetts' attempted ban of Zohydro ER and said efforts to trump FDA's authority threaten the integrity of science-based regulation on an episode of BioCentury This Week television that aired on Sunday (see BioCentury This Week, April 20).
Zogenix was off $0.20 to $2.81 on Wednesday.
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).
Biogen Idec recorded $505.7 million in 1Q14 revenues for Tecfidera dimethyl fumarate, which the company has marketed in the U.S. since April 2013. The European Commission approved the multiple sclerosis drug in February; the company launched Tecfidera in Germany.
The company raised its 2014 guidance and now expects full-year EPS of $11.35-$11.45 on revenue growth of 26-28%. In January, Biogen Idec introduced 2014 guidance and said it expected full-year EPS of $11-$11.20 on revenue growth of 22-25%. The Street was expecting EPS of $11.32 on revenues of $8.6 billion, which would represent 25% growth over 2013 revenues of $6.9 billion.
Biogen Idec was up $0.55 to $306.75 on Wednesday.
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.
Kala is developing a pipeline of topical ophthalmic products based on its mucosal penetrating particle (MPP) technology, which is designed to achieve high, sustained local drug concentrations with low systemic exposure. The company's lead program is LE-MPP, which is a formulation of the steroid loteprednol etabonate. This year, Kala plans to start a Phase III trial to treat postoperative inflammation and pain following cataract surgery; and Phase II trials to treat dry eye disease, blepharitis and diabetic macular edema and retinal vein occlusion.
Bausch + Lomb Inc., now part of Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX), markets loteprednol etabonate as Lotemax in eye drop, ointment and gel formulations.
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.
Aerpio's AKB-9778 is in Phase II testing for diabetic macular edema (DME), with top-line data expected in 1Q15. The product is a tyrosine kinase receptor 2 (Tie2) activator. Anemia company Akebia Therapeutics Inc. (NASDAQ:AKBA) spun out Aerpio in 2012 (see BioCentury, April 16, 2012).
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).
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.
Quotient markets reagents for characterizing blood and serological disease screening for the transfusion diagnostics market. The company also is developing MosaiQ, an automated high throughput instrument for blood grouping and serological disease screening. Quotient reported $14.4 million in revenues for the fiscal year ended March 31, 2013.
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.
Next quarter, Spectrum plans to submit an NDA to FDA for the product, which is melphalan delivered via Captisol sulfobutylether beta-cyclodextrin technology from Ligand Pharmaceuticals Inc. (NASDAQ:LGND). The product is propylene glycol-free. According to Spectrum, propylene glycol is associated with renal and cardiac side effects.
Spectrum was up $0.28 to $7.18 on Wednesday. Ligand was off $1.01 to $69.18 on the day.
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.
Data will be presented at the International Symposium on Amyloidosis next week. In 4Q14, Prothena plans to start a Phase II/III trial of the mAb targeting amyloid. The company said AL amyloidosis affects about 15,000 patients in the U.S. and Europe.
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.
Sylvant has been available in the U.S. under a named patient program, and J&J said it will formally launch the drug in the U.S. in a few weeks. The wholesale acquisition cost (WAC) for a 100 mg vial is $833. Sylvant is dosed at 11 mg/kg every three weeks until treatment failure, which translates to an annual WAC of $127,449 for a 75 kg person.
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.
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