Gazette.Net: MedImmune parent, Amgen launch partnership


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Amgen and AstraZeneca, through its global biologics division, MedImmune of Gaithersburg, are partnering to develop and commercialize five monoclonal antibodies to treat a wide range of conditions, from psoriasis to Crohn’s disease and asthma.

AstraZeneca of London will pay $50 million to the Thousand Oaks, Calif., biotech, with both sharing costs and profits. AstraZeneca will pay about 65 percent of the costs through 2014, according to a joint statement. Thereafter, costs will be split equally.

AstraZeneca is to lead the development and commercial strategy of three candidates, AMG 139, AMG 157 and AMG 181, which are being studied to treat Crohn’s disease, asthma and ulcerative colitis, respectively. Amgen will spearhead efforts regarding brodalumab, or AMG 827, which is being investigated for treating psoriasis, psoriatic arthritis and asthma; and AMG 557 for autoimmune diseases such as systemic lupus erythematosus.

“We are delighted to join forces with Amgen in developing and commercializing these novel clinical-stage assets that add value to our pipeline and build on our expertise in biologics,” AstraZeneca CEO David Brennan said in the statement. “This creative collaboration will make the most of both companies’ respective capabilities, including AstraZeneca's extensive global reach, to help bring these potentially innovative treatment options for a variety of respiratory and inflammatory diseases to patients around the world.”

Amgen will benefit from the “strong respiratory, inflammation and asthma development expertise of MedImmune,” the companies said.

“We are very excited at the prospect of collaborating with a well-respected organization like AstraZeneca to advance our inflammation pipeline,” said Kevin Sharer, chairman and CEO at Amgen, which recently acquired Rockville’s Micromet. “We believe this collaboration has the potential to bring more therapies to patients sooner, across more geographic areas.”

In other Maryland bioscience industry news:

Maryland biotechs competing to develop a next-generation anthrax vaccine have reported some new sources of capital to help finance their efforts.

Emergent BioDefense Operations Lansing, a wholly owned subsidiary of Emergent BioSolutions of Rockville, reported an award from the Centers for Disease Control and Prevention for as many as 44.75 million doses of its BioThrax vaccine worth as much as $1.25 billion during the next five years.

The contract was effective last Sept. 30, but was just recently reported by Emergent to the Securities and Exchange Commission. The first doses were delivered in December. BioThrax is the only federally approved anthrax vaccine.

So far, $225 million has been committed under the CDC contract, according to the SEC filing. The rest of the award is subject to available federal funding.

Meanwhile, PharmAthene of Annapolis reported a new $2.5 million loan and $5 million line of credit from GE Capital, Healthcare Financial Services.

“Our expected 2012 monthly cash burn is less than $500,000 per month based on currently projected activities on our contracts,” CFO Linda L. Chang said in a statement. “Given that PharmAthene had $19.2 million in cash and cash equivalents, short-term investments, and net receivables as of Dec. 31, 2011, this financing provides an additional liquidity cushion until the time in 2013 when we anticipate receiving final resolution of the litigation with Siga Technologies.”

PharmAthene has been embroiled in a court battle for years with Siga Technologies over revenues from a smallpox treatment.

GlaxoSmithKline has reported promising data from phase 3 trials of a type 2 diabetes treatment it licensed from Human Genome Sciences in Rockville.

Under the terms of the companies’ 2004 agreement, HGS is entitled to fees and milestone payments that could reach $183 million, plus sales royalties if the treatment, called albiglutide, is commercialized. So far, HGS — whose proprietary albumin-fusion technology was used to create the treatment — has received $33 million.

The British pharma giant is conducting eight phase 3 trials of the treatment, and this week reported receiving results from seven. Two studies have been completed. Initial results indicate that albiglutide, which is injected, was more effective than a current treatment, with some weight loss also observed.

The new data “provide an early indication of the profile of the investigational product, broadly aligned with the results of the two completed studies,” GlaxoSmithKline said. “These two-year data support progression and will be used for regulatory filings.”

Cerecor, a Baltimore biotech developing nervous system treatments, reported raising $22.1 million in a preferred stock offering from 156 investors — surpassing its $15 million target. The company was launched in May.

“The completion of this financing is an important step in bringing our lead product, FP01 for the treatment of chronic and acute cough, to the market and to support our early preclinical efforts in cognition and schizophrenia,” Blake M. Paterson, co-founder and CEO, said in a statement.

Armed with new positive data, Sucampo Pharmaceuticals plans to apply within a few months for regulatory approval to market its candidate to treat constipation caused by opium-based painkillers such as codeine and morphine in patients who don’t have cancer.

Results from the phase 3, 36-week trial, which involved 439 subjects at 116 sites, showed lubiprostone to be effective, with minimal adverse side effects, according to a statement from the Bethesda company. The fresh data support previous results announced in February and bolster the company’s hopes for Food and Drug Administration approval.

“We are highly pleased with the long term safety profile and efficacy observed in this phase 3 trial of lubiprostone” in opioid-induced bowel dysfunction, CEO Ryuji Ueno said in the statement. “These data will be an important part of our supplemental new drug application. With these data and those of the previously completed phase 3 trials, we now have all the necessary data for submission and are preparing to file the [application] mid-year with a request for priority review.”

Constipation is one of the most common side effects of taking opioids, affecting about 80 percent of patients, according to Sucampo.

The company already markets lubiprostone under the name Amitiza to treat chronic idiopathic constipation and irritable bowel syndrome with constipation.

Last year, Amitiza sales in the U.S. totaled $226.4 million, with prescriptions growing 6.6 percent from 2010, according to Sucampo’s annual report.

The pulsing electronic skin patch made by BioElectronics may help repair and grow bone, according to a new study in the peer-reviewed Journal of Craniofacial Surgery.

The study used the Frederick company’s ActiPatch to transform two cell lines of pluripotent osteoprogenitor cells into bone.

“It has been clear to us for a long time that our products stimulate cellular repair and growth,” Ian Rawe, research director, said in a statement. “We have our own limited bone growth study, so we are therefore very excited by this excellent research, which may lead to an effective method for bone regeneration and aid in reconstructive surgery."