The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) acquired exclusive, worldwide rights to cancer candidate NLG919 from NewLink Genetics Corp. (NASDAQ:NLNK) for $150 million up front. NewLink is eligible for more than $1 billion in milestones, plus escalating double-digit royalties, and retains co-commercialization rights in the U.S.
NLG919 is an oral small molecule indoleamine 2,3-dioxygenase (INDO; IDO) pathway inhibitor that is in Phase I testing to treat recurrent advanced solid tumors. NewLink declined to disclose when it expects data from the study, which began in December 2013.
Genentech spokesperson Nadine Pinell said the company intends to investigate NLG919 in combination with Genentech's investigational cancer immunotherapies including MPDL3280A, a human mAb against programmed cell death 1 ligand 1 (PD-L1; B7-H1; CD274), and MOXR0916, a human mAb against OX40 ligand (OX40L).
Genentech is responsible for NLG919's development and commercialization costs. The two companies also will collaborate to develop additional compounds addressing tryptophan-2,3-dioxygenase (TDO) as well as IDO, with Genentech supplying funding.
NewLink closed up $2.09 to $31.44 on Monday.
AbbVie Inc. (NYSE:ABBV) and Shire plc (LSE:SHP; NASDAQ:SHPG) on Monday agreed to terminate their proposed acquisition, less than a week after the pharma said it was reconsidering the deal. AbbVie must now pay Shire a $1.6 billion breakup fee, and investors still holding out hope for an eventual deal now will have to wait a year under U.K. law.
Shire accepted AbbVie's sweetened L31.4 billion ($53.8 billion) buyout offer on July 18. But on Oct. 16, the pharma said it was reconsidering due to the U.S. Department of Treasury's proposed rule changes to remove the benefits of tax inversions.
On Monday, AbbVie Chairman and CEO Richard Gonzalez said on a conference call that changing U.S. tax rules have created an "environment of risk and uncertainty" and that they "destroyed the value in this transaction." He said the decision to terminate the deal was mutual and warned that U.S. businesses would be at a competitive disadvantage without tax reform.
Shire said its board concluded there was "no realistic prospect" of AbbVie completing the deal and wanted to resolve the situation quickly.
Gonzalez noted the proposed deal's strategic benefits remain unchanged. But the U.K. Takeover Code prohibits AbbVie from making a new offer for Shire within 12 months without the consent of the U.K. Takeover Panel.
The pharma also announced a new $5 billion stock buyback program and boosted its quarterly cash dividend to $0.49 a share from $0.42, payable on Feb. 13, 2015, to stockholders of record as of Jan. 15.
The news came after market close. Shire closed up $5.43 to $184.59 on Monday. AbbVie gained $1.04 to $54.41.
FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted 7-0 to recommend approval of Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN) to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The PDUFA date is not disclosed; Novartis submitted the BLA in October 2013.
Panelists agreed secukinumab showed efficacy and that the increased efficacy of a 300 mg dose vs. a 150 mg dose outweighed safety concerns, regardless of patient weight. Members said a 150 mg dose could be appropriate in special cases.
The primary safety concern in trials was an increased risk of infection, which panelists agreed was clinically manageable.
Panelists expressed interest in future studies of a 450 mg dose for certain cases, such as patients 90 kg and heavier and those who respond inadequately to a 300 mg dose. Some committee members also said Novartis should expand its postmarket study plans to capture more rare events, such as occurrence of particular cancers or autoimmune diseases.
If FDA follows the panel's recommendation, the human IgG1 mAb targeting interleukin-17A (IL-17A) would be the first therapy targeting IL-17 signaling approved for the indication.
The Taiho Oncology Inc. subsidiary of Taiho Pharmaceutical Co. Ltd. (Tokyo, Japan) said FDA has granted Fast Track designation for its TAS-102 to treat refractory metastatic colorectal cancer (mCRC) and that the company has started a rolling NDA submission to the agency.
TAS-102 is an oral formulation of the antineoplastic nucleoside analog trifluridine combined with tipiracil hydrochloride, an inhibitor of the FTD-degrading enzyme thymidine phosphorylase. In March, it was approved in Japan under the name Lonsurf to treat unresectable advanced or recurrent colorectal cancer refractory to standard therapies based on data from a Japanese Phase II trial. The U.S. submission is based on the Phase III RECOURSE trial of the compound in 800 patients with mCRC.
Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co. Ltd. (Tokyo:4578), has said TAS-102 will be a springboard for the company's plans to expand into the U.S. and Europe with its pipeline of cancer products (see BioCentury, June 3, 2013).
Mongersen (GED-0301) from Celgene Corp. (NASDAQ:CELG) produced clinical remission rates as high as 65.1% in a Phase II trial in 166 patients with moderate to severe Crohn's disease, according to an abstract published in advance of the United European Gastroenterology's meeting in Vienna.
In the trial, 55% of patients receiving 40 mg/day of mongersen and 65.1% of those receiving 160 mg/day achieved clinical remission compared with 9.5% of placebo patients (p<0.0001 for both). A cohort receiving 10 mg/day achieved a clinical remission rate of 12.2%, which was not significantly better than placebo.
The study's primary outcomes were clinical remission, defined by a CDAI score less than 150 at day 15 and maintained for more than two weeks, and safety. Mongersen was well-tolerated, and toxicities associated with systemically active antisense therapies were not observed.
The study's secondary endpoint is clinical response, defined as a CDAI score reduction of 100 points at day 28. Those rates were dose-dependent: 36.6%, 57.5% and 72.1% for the low, medium and high doses compared with 16.7% for placebo.
Celgene said it plans to start Phase III testing of mongersen shortly. The company paid $710 million up front to obtain exclusive, worldwide rights to the antisense oligonucleotide targeting SMAD family member 7 (MADH7; SMAD7) from Nogra Pharma Ltd. (Dublin, Ireland) in April. Nogra is eligible for $1.9 billion in milestones, plus tiered single-digit royalties.
Celgene gained $3.88 to $92 on Monday.
HealthCare Royalty Partners closed its third fund, HealthCare Royalty Partners III, at $1.5 billion, which the firm said exceeded its original target by over 75%.
Managing Partner Todd David told BioCentury the firm had targeted $850 million. Investors included the state of Florida, Strathclyde Pension Fund, Missouri Local Government Employees Retirement System and HESTA.
The fund will make 25 to 30 investments over four years in pharmaceutical, biotech and specialty pharma, medical devices and diagnostics. Deals will range from $20-$200 million, with two-thirds invested in the U.S. The focus elsewhere is Western Europe, Japan and Australia.
Credit Suisse Securities LLC and Threadmark LLP served as placement agents in Australia and Europe, respectively. Goodwin Proctor LLP was an advisor.
Since closing its $1 billion second fund in December 2011, the firm has deployed $900 million across 23 deals. HealthCare Royalty Partners now has over $3 billion under management, employing a variety of financing vehicles including debt and royalty monetization.
Science and technology development firm PureTech Ventures (Boston, Mass.) raised $55 million from Invesco Perpetual and other investors including endowments, angels and pharma companies. The funding builds on about $32 million in prior investments, according to CEO Daphne Zohar.
PureTech typically provides seed funding to new companies that are set up as operating subsidiaries, then seeks outside investors as the newcos mature. Zohar said the new round will allow it to provide $2-$10 million in follow-on funding to multiple programs.
Zohar said Invesco acted as a financial investor and did not receive special rights to any PureTech companies, and noted that Invesco could invest an additional $10-$50 million in any of PureTech's pipeline programs.
Among PureTech's programs are Vedanta Biosciences Inc., which is developing therapies derived from the microbiome, and Gelesis, which is developing an encapsulated device that swells in the stomach and small intestine to control appetite.
Zohar said the firm will use some of the funds to start new programs as well, and is considering projects in childhood disorders, digital medicine, population health and nutrition.
Viamet Pharmaceuticals Inc. (Durham, N.C.) withdrew its proposed IPO on NASDAQ. The company did not provide a reason in its SEC filing and did not respond to inquiries. In July, the infectious disease play filed to raise up to $75 million in an offering underwritten by Piper Jaffray; Wells Fargo and Stifel.
Last month, Viamet said it expected to start Phase IIb trials of VT-1161 by year end. It is studying the small molecule metalloenzyme inhibitor of cytochrome P450 C-14 alpha demethylase (CYP51) to treat recurrent vulvovaginal candidiasis and onchomycosis.
DBV Technologies (Euronext:DBV) finalized the details of its planned global offering of shares that will include a dual-listing of ADSs on NASDAQ.
The allergy specialist now plans to sell up to 2.7 million ordinary shares, with each ADS representing one-half of an ordinary share. DBV's orginal SEC filing called for the sale of up to 3 million shares, with each ADS representing one ordinary share.
DBV closed at EUR 36.83 on Euronext on Monday, down EUR 0.37. The shares closed at EUR 25.57 on the last trading day before Sept. 22, when the company reported positive Phase IIb data for its Viaskin Peanut (DBV-712) allergy treatment and filed to raise up to $96.1 million in the follow-on.
The product delivers peanut proteins epicutaneously using the company's Viaskin patch technology. Last month, DBV said Phase III testing would begin in 12-18 months.
Viaskin Peanut has Fast Track designation in the U.S. to treat peanut allergy. In June, the Consortium of Food Allergy Research (CoFAR) completed enrollment in the U.S. Phase II CoFAR6 trial of Viaskin Peanut once daily for 30 months.
Citigroup Global Markets, Leerink; and Bryan, Garnier are joint global coordinators and joint book-running managers of the global offering. Trout Capital is joining as a U.S. underwriter.
The White House Office of Science and Technology Policy (OSTP) and HHS announced the U.S. government has halted funding for "gain of function" (GOF) research that could increase the pathogenicity or respiratory transmission of influenza, SARS and MERS viruses. The hiatus will remain in effect while the government carries out a risk-benefit assessment and adopts a new federal policy regarding GOF research. This process is expected to end in 2015.
The assessment will include drafting of recommendations by the National Science Advisory Board for Biosecurity (NSABB), in conjunction with public consultations organized by the National Research Council. NSABB will meet on Oct. 22 to begin drafting recommendations.
In a statement last Friday, NIH Director Francis Collins noted NIH has funded GOF experiments "because they help define the fundamental nature of human-pathogen interactions, enable the assessment of the pandemic potential of emerging infectious agents, and inform public health and preparedness efforts."
Nevertheless, he added, these studies "also entail biosafety and biosecurity risks, which need to be understood better."
Collins said NIH will not provide any new funding for GOF research and called on researchers to voluntarily pause existing projects, whether or not with federal funds, until the new government policy is determined.
The announcement follows revelations last summer about two incidents involving pathogen security at CDC laboratories. In an interview on BioCentury This Week television at the time, Carlos Moreno of Emory University School of Medicine argued in support of greater restrictions for gain of function studies. On the other side, Daniel Perez of the University of Maryland told BioCentury that such restrictions may limit the ability of researchers to understand how viruses such as influenza can become airborne (see BioCentury This Week television, Aug. 31).
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