Pharmacy benefit manager Express Scripts Holding Co. (NASDAQ:ESRX) released a list of 73 therapies it will not cover in 2016.
Diabetes drugs Onglyza saxagliptin and Kombiglyze XR from AstraZeneca plc (LSE:AZN; NYSE:AZN) were moved to the excluded list in 2016 from preferred status in 2015. Onglyza is a dipeptidyl peptidase-4 (DPP-4; CD26) inhibitor and Kombiglyze XR is a fixed-dose combination of once-daily saxagliptin and extended-release metformin.
The PBM also added drugs to its 2016 formulary that had previously been excluded, including the DPP-4 inhibitor Tradjenta linagliptin from Boehringer Ingelheim GmbH (Ingelheim, Germany) and Eli Lilly and Co. (NYSE:LLY).
Nine new drug classes were added to the formulary, including weight loss drugs. Obesity drug Qysmia, a low-dose combination of phentermine and topiramate from Vivus Inc. (NASDAQ:VVUS), was excluded, while phentermine was listed as the preferred option. Neither of two other weight loss drugs, Contrave naltrexone/bupropion from Orexigen Therapeutics Inc. (NASDAQ:OREX) and Belviq lorcaserin from Arena Pharmaceuticals Inc. (NASDAQ:ARNA) and Eisai Co. Ltd. (Tokyo:4523), was excluded.
Four drug classes on the 2015 exclusion list did not appear on the 2016 list, including interferon beta drugs for multiple sclerosis (MS), long-acting opioid oral analgesics, pulmonary anti-inflammatory/beta agonist combination inhalers and pegylated interferons for hepatitis.
The PBM said less than 0.5% of the 25 million members using the formulary will be affected by the exclusions.
Express Scripts said it will look at new drugs such as the PCSK9 inhibitors as they come to market. The 2016 formulary does not yet include any of the new cholesterol-lowering agents. FDA approved Praluent alirocumab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN; NYSE:SNY) on July 24. Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN) is under review with an Aug. 27 PDUFA date.
Express Scripts said it will update the formulary later this year to reflect its indication-based pricing model for cancer drugs (see BioCentury, July 20).
Vivus Inc. (NASDAQ:VVUS) lost $0.22 (13%) to $1.51 after it announced a restructuring plan that will halve from 100 to 50 its sales staff for Qsymia phentermine/topiramate. The company had eliminated another 50 Qsymia sales positions last quarter.
Vivus reported $14 million in 2Q15 sales of Qsymia, up from $11 million in 2Q14. CEO Seth Fischer said on a conference call that the market for anti-obesity drugs "has developed at a substantially lower rate than expected," as generic phentemine still accounts for more than 80% of prescription volume.
The company also said it has met with FDA to discuss redesigning its AQCLAIM cardiovascular outcomes trial (CVOT) of Qsymia to cut costs. Fischer said a dialogue is ongoing concerning "alternative proposals that will satisfy the existing requirements."
Vivus said it would eliminate a total of 60 positions. The company reported a non-GAAP loss of $0.19 per share, beating the consensus estimate of $0.24.
Separately, Express Scripts Holding Co. (NASDAQ:ESRX) said it would exclude Qsymia from its 2016 formulary (see above).
Celgene Corp. (NASDAQ:CELG) filed four motions this week with the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office requesting sanctions to dismiss inter partes review (IPR) petitions submitted by the Coalition for Affordable Drugs. The Coalition, controlled by hedge fund manager Kyle Bass, filed the IPR petitions in April to invalidate two of Celgene's patents on Revlimid lenalidomide (see BioCentury Extra, April 23).
In its motions, Celgene accused the Coalition of using the IPR process to manipulate the stock prices of public companies. Celgene also alleged that before the IPRs were filed, someone associated with the Coalition had attempted to obtain payment from Celgene in exchange for witholding the petitions. Celgene asked the board to dismiss the petitions as a sanction against the Coalition "for their abuse and improper use" of IPR proceedings.
The Coalition is a subsidiary of Hayman Credes Master Fund, which is operated by Hayman Capital Management. Hayman Capital said Celgene's motion "is another farcical legal attempt to avoid a public, merit-based review of its undeserved Revlimid monopoly." The hedge fund plans to submit a formal response on Aug. 11.
Cancer play Unum Therapeutics Inc. (Cambridge, Mass.) named Geoffrey Hodge SVP of operations. Hodge was bioprocess technology leader at GE Healthcare Life Sciences.
Single doses of Ebola vaccine rVSV-EBOV (VSV-ZEBOV;VSV-EBOV) showed 100% efficacy in an interim analysis of an open-label Guinean Phase III trial. Data from the World Health Organization (WHO)-sponsored trial were published in The Lancet on Friday.
Merck & Co. Inc. (NYSE:MRK) gained exclusive, worldwide rights to rVSV-EBOV from NewLink Genetics Corp. (NASDAQ:NLNK) in 2014. The vaccine was originally developed by the Public Health Agency of Canada.
The interim analysis included 7,561 individuals at risk for Ebola who received either immediate vaccination or delayed vaccination 21 days after randomization with a single 20 million plaque-forming units (PFU) dose of rVSV-EBOV.
In the immediate vaccination group, there were no cases of laboratory-confirmed Ebola with onset of symptoms at least 10 days after randomization, the prespecifed primary outcome, vs. 16 cases in the delayed vaccination group. Immediate vaccination with rVSV-EBOV showed 100% efficacy (95% CI: 74.7, 100; p=0.0036).
WHO said randomization in the trial stopped on July 26, and all future participants will receive the vaccine immediately. WHO spokesperson Daniela Bagozzi said the agency thinks "if interim results are foolproof, we can probably get to zero cases in Guinea in a few weeks."
Merck spokesperson Pamela Eisele said the company plans to use data from ongoing trials to support worldwide regulatory submissions for rVSV-EBOV. The recombinant vesicular stomatitis virus (rVSV) vaccine expressing an Ebola virus protein is also in the CDC-led Sierra Leonian Phase III STRIVE trial. Eisele declined to comment on a regulatory timeline.
NewLink gained $0.99 to $52.15 on Friday.
AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) raised $200.8 million through the sale of 3.1 million shares at $63.75 in a follow-on underwritten by Jefferies; Barclays; Leerink; Guggenheim; and Raymond James. The specialty pharma proposed the offering after market close on Wednesday, when its shares were valued at $64.95; AMAG lost $0.87 to $63.90 on Friday.
AMAG is acquiring Cord Blood Registry (San Bruno, Calif.) for $700 million in cash. The parties expect the deal to close this quarter (see BioCentury Extra, June 29).
FDA posted PDUFA fees for drug, biosimilar, and medical device marketing applications for FY16.
Fees for drug applications containing clinical data will be $2.4 million, or $1.2 million without clinical data; last year's fees were $2.3 million per clinical application and $1.2 million per non-clinical application. FDA will charge a product fee of $114,450 for each approved drug in an application, and an establishment fee of $585,200 for each facility manufacturing the product.
For biosimilars, FDA will charge a yearly $237,420 biological product development fee (10% of the PDUFA fee) for sponsors that have filed an IND but not a marketing application. The same application, product, and establishment fees for drug applications also apply to biosimilars.
FDA's standard premarket application fee for medical devices will be $261,388 in FY16; an annual reporting fee of $9,149 (for class III devices) and an establishment fee of $3,845 will also apply.
FDA anticipates $851.5 million in PDUFA revenue in FY16.
Chris Hickey, formerly director of the China country office at FDA, joined Pfizer Inc. (NYSE:PFE) as senior director of public affairs for Asia-Pacific. FDA's new China office director is Leigh Verbois, who was director of the Office of Regional and Country Affairs in the Office of International Programs at FDA.
The Pharmaceutical Research and Manufacturers of America named Rajesh Ranganathan VP of science and regulatory advocacy, effective Aug. 3. Ranganathan was director of the Office of Translational Research at the National Institute for Neurological Disorders and Stroke (NINDS) in NIH.
FDA will hold a public meeting on Oct. 15 to discuss non-tuberculous mycobacterial lung infections. The meeting is part of FDA's Patient-Focused Drug Development initiative, in which the agency is holding public meetings to discuss the impact of diseases, the measures of benefit that matter most to patients and the adequacy of available treatment options.
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