Biologics

J&J psoriasis drug may carry cancer risk

Maureen Martino — Fri, 13 Jun 2008 11:19:19 -0400

Outside experts are preparing to review ustekinumab, Centocor's injectable treatment for severe psoriasis. Two Phase III studies demonstrated positive results, but staffers will have to consider possible increased risk of cancer associated with the drug. Animal studies indicated that the drug may encourage tumor growth. "Long-term use of ustekinumab may lead to increased risk of tumor development in psoriasis patients," FDA reviewers noted. Centoror, a division of Johnson & Johnson, is expecting an FDA decision by September.

Though ustekinumab may have produced impressive results in trials, J&J may have an uphill battle convincing insurers to cover the expensive drug for patients with severe forms of psoriasis. Insurers would prefer members to stick with older, cheaper psoriasis drugs rather than allow them to switch to one of the newer biologics that have hit the market.

- see this report for details

Global demographic trends threaten drug industry

Wed, 14 May 2008 06:59:54 -0400

You can file the following under the category of really, really bleak forecasts:

The rising cost of healthcare in the developing world matched by an aging population is creating a perfect storm for drug developers that threaten their entire industry, according to an upcoming report by AT Kearney. We are moving from a world in which six or seven workers support one person in retirement to a ration of three to one, warns the report, and that will force healthcare services all over the world to restrict their support to essential services. Expensive biologics aimed at extending the lives of patients won't be included. There will also be much greater pressure on developers to match a recent agreement Johnson & Johnson made with the National Health Service in the UK to reimburse the NHS for each patient who doesn't respond to Velcade. And as developing countries grow their populations will demand new therapies that target diseases like malaria, tuberculosis and HIV.

- read the story from Dow Jones

Can Big Pharma effectively develop new drugs?

Fri, 04 Apr 2008 07:59:57 -0400

When it comes to drug development, is bigger really better? That is the question Borje Eckholm, president and CEO of Investor AB--and one of AstraZeneca's biggest shareholders--poses in the London Times. Big Pharma is under increasing pressure to churn out blockbuster drugs while at the same time control costs, fend off generic competition and create shareholder value. Eckholm thinks the vertically integrated pharma model can't effectively meet all those demands.

"You have to ask yourself: Do you have economies of scale in R&D? It's not clear but one of the fundamental ways that companies create value for shareholders is strong R&D. It raises the question: is big better? Maybe you have to split it up into smaller parts." He suggest that Big Pharma would be better off outsourcing projects to smaller developers who posses the independent spirit needed to discover groundbreaking new drugs.

Some of the industry's biggest players have indicated that reorganization is necessary. Pfizer, for instance, has set up a biotech incubator to foster growth. Meanwhile, AstraZeneca has established a biotech focus, merging purchases Cambridge Antibody Technology (CAT) and MedImmune into one biologics powerhouse. The company also spun off its Swedish R&D facility for gastrointestinal therapies.

- read more in this London Times report

ALSO: Can pharma police its own globalization? Report

Follow-on legislation follows a twisted path in DC

Mon, 17 Mar 2008 07:59:57 -0400

BIO is toasting proposed new legislation that would provide more than 14 years of patent protection on a biologic. Needless to say, the generics crowd is just a tad disappointed by the bill, saying that patients would have to wait decades before they could benefit from any lower prices. "For the countless patients who are choosing between paying for their medicines and putting food on their tables, waiting decades is simply not an option," said the Generic Pharmaceutical Association. BIO feels a lengthy period of patent protection is the only fair option, given the time it takes to move a biologic to regulatory approval.

As the Wall Street Journal's blogsters point out, new legislation providing a regulatory pathway for biologics gets a thumb's up from most everyone--but no one agrees just how lawmakers should do it. One other commonly agreed point: Starting out, the FDA is likely to take it one biologic at a time, deciding when and how for each program.

- read the Generic Pharmaceutical Association statement
- read the report from the Wall Street Journal

Related Articles:
Waiting game continues for biogenerics. Report
Insulin debate spurs push for generic biologics. Report
Teva plans aggressive move into biogenerics. Report
Budget has mandate for biogeneric approvals. Report

Teva plans aggressive move into biogenerics

Fri, 14 Mar 2008 07:59:57 -0400

Anyone looking for some real insight into Teva's growth strategy should spend some time with a new Globes article that digs in deep. Shlomo Yanai, who stepped in as CEO a year ago, plans to double sales by introducing a series of biogenerics and advancing new biologics. By 2012, Yanai expects to have the Israeli company earning $20 billion a year as he builds a pharma/biotech/generic hybrid.

"Drugs based on synthetic-organic chemistry are reaching the end of the road, and we can see this by the falling number of new drugs receiving approval every year," he tells Globes. "On the other hand, biology, or drugs based on live organisms, are growing at a faster rate."

Yanai explains that Teva's $400 million deal to buy CoGenesys fits in neatly with the overall strategy. "One of the moves we recently took was the acquisition of CoGenesys which has developed a technology that fuses human albumin with biological molecules. Since the patents in the field will only start lapsing towards 2013-2014, drugs will not become available en-masse until then. We believe, however, that our first biogeneric drug will come onto the market in Europe before then, in 2009."

- read the story from Globes
- and read the report from the Wall Street Journal

BioCon buys stake in German pharma company

Fri, 15 Feb 2008 06:59:56 -0500

Fulfilling an earlier promise to acquire a company, Bangalor-based BioCon has spent €30 million to purchased a 70 percent stake in German pharmaceutical company AxiCorp. The deal will allow BioCon to market its injectable insulin, Insugen, in Europe; it will be followed by other generics, biosimilars and biologics.

In January BioCon indicated that it was exploring ways to promote its products in North America and Europe, and planning to spin off its clinical research group. According to Biocon's release, this marks the first of several acquisitions Biocon has planned following the sale of its enzymes business last year. "We are very focused on becoming a key player in insulin globally," said a BioCon spokesperson. "We can deliver through a combination of Biocon's low cost manufacturing and AxiCorp's low cost distribution."

- here's the release
- and check out this Economic Times report

Related Articles:
Biocon CEO plans acquisition, spin-off. Report
Biocon plots new deals after sale of enzymes business. Report
India focuses on biosimilars. Report

Amgen CEO touts blockbuster potential of D-mab

Thu, 14 Feb 2008 06:59:54 -0500

Amgen CEO Kevin Sharer dropped by The Wall Street Journal to tout the company's chances in developing denosumab (D-mab) into a badly needed blockbuster. The discovery program began in an Amgen lab when researchers observed that one of the knockout mice it had developed during gene disabling research work had grown huge. "We noticed, hey that's a really big mouse," Sharer told the Journal. "It's really got big bones."

It's also got really big market potential. Amgen believes that D-mab, which blocks the protein expressed by the gene knocked out in the mice, is worth at least a billion dollars a year, which would make up for some of the market it has lost in anemia drugs. Sharer also said that the drug would be priced closer to $1,000 a year--a fraction of the $10,000 a year tab that many biologics run.

- read the report in the Wall Street Journal

Related Articles:
Amgen's D-mab meets trial goal. Report
Denosumab: Amgen's salvation? Report
Amgen touts progress in two key programs. Report
Amgen discusses the future with analysts. Report

Budget has mandate for biogeneric approvals

Tue, 05 Feb 2008 06:59:57 -0500

Buried in the modest 5.7 percent budget hike for the FDA is a provision that the government will seek authority to begin approving generic versions of biologics. Despite heavy support for the measure, lawmakers failed to get a bill in 2007 that would mandate a regulatory pathway for follow-on biologics, or biogenerics. The 1984 generic drug law excludes most biotech products, a feature that has enhanced the sector for investors and aroused the fiercely protective nature of a host of industry lobbyists. This time around, though, biogeneric legislation could get the boost it needs if the White House actively pursues it.

- read the report in the Wall Street Journal

ALSO: Opponents of a patent reform bill that changes the way damages are assessed in patent reform cases got a boost from the Bush Administration. Report

PLUS: Any big fix at the FDA may have to wait for a new president. The White House's proposed budget includes a funding increase of just 5.7 percent for the agency, a hike that's significantly absorbed by inflation. Report

Related Articles:
Waiting game continues for biogenerics. Report
Dr. Reddy's make risky biogenerics move. Report
Lawmakers propose pathway for approving biosimilars. Report

Celgene touts mid-stage psoriasis results

Tue, 05 Feb 2008 06:59:56 -0500

Researchers for Celgene are changing the dosing and duration of their tests of an experimental psoriasis drug after seeing a significant reduction in severity and symptoms in a mid-stage study. A 260-patient study of CC-10004 demonstrated that 24.4 percent of patients treated with 20 milligrams of CC-10004 every 12 hours had a 75 percent or greater reduction in psoriasis severity and symptoms. A placebo registered a 10.3 percent reduction. Patients can now get doses of 30 mgs for up to six months and Celgene will expand the trial to include related conditions. No serious side effects were reported.

- see this release
- check out the AFX report

Related Articles:
Celgene goes global with $2.9B Pharmion buyout. Report
Array partners with Celgene, nets $40M upfront. Report
Celgene accelerates program on positive psoriasis data. Report
Insurers shun new biologics for psoriasis. Report

SPOTLIGHT: Special Report: 2007 FDA approvals

Tue, 15 Jan 2008 06:59:53 -0500

As has been pointed out on many occasions, 2007 was a lean year for new drug approvals. The FDA approved only 15 new molecular entities (NMEs) last year--17 if you include two new biologics (Soliris and Mircera) OK'd by CDER. Here's a look at the drugs that made it through the rigorous review process and earned FDA approval in 2007. List

Incyte causes stir with experimental drug data

Wed, 09 Jan 2008 06:59:54 -0500

Incyte made a stir at JP Morgan with positive early-stage results for its experimental drugs aimed at rheumatoid arthritis and diabetes. Its shares jumped about 25 percent on the news. Chief Executive Dr. Paul Friedman said early data from INCB18424 appear to show "at least equal, and possibly superior," results compared to other biologics, adding that the drug was well tolerated.

- read the release

Related Articles:
Focus shifts at Incyte after HIV halt. Report
Pfizer to pay up to $803M for rights to Incyte program. Report
Incyte shares drop after FDA requires new Phase II. Report

China's WuXi buys Apptec for $151M

Fri, 04 Jan 2008 06:59:57 -0500

WuXi PharmaTech, a provider of R&D outsourcing services, has agreed to pay $151 million for Minnesota-based medical research group Apptec. WuXi gains Apptec's biologics capabilities along with U.S. market presence.

Analysts aren't so wild about the move. WuXi's success is due to the fact that scientists in China are paid about $30,000 a year--a fraction of the going rate for U.S. scientists, who can make ten times as much. WuXi provides low cost R&D to pharmaceutical companies looking to cut some cash out of the bottom line. Acquiring a U.S.-based asset--along with its highly-paid scientists--could have quite an impact on that business model.

- see this release from WuXi
- read the Wall Street Journal article

Related Articles:
Trend: Research (and marketing) heads to Asia. Report
CRO market hits $14B. Report
Asian CRO gains $22M in second round. Report
China pushes drug development as R&D soars. Report

Dealmaking stays big even as the markets tremble

Wed, 02 Jan 2008 06:59:56 -0500

The credit crunch could play a miserly role in hobbling biotech, but I have yet to see it. As long as big pharma sees its future in biologics, you can expect to see investors laying their bets to benefit from that trend. The JP Morgan meeting in January is a reliable harbinger of the level of excitement surrounding deal-making in biotechnology. That event is still a few days away, but the strong buzz around the meeting is a positive sign that 2008 will go down as a good year in the industry.

There is no indication, though, that the stock market will play a major supporting role in the near term. Unfortunately, a chilly Wall Street for IPOs--and no one can reliably predict when that will come to an end--can only make merger options even more attractive. Some great biotech companies in the making will be bought out and blended into pharma, and they're likely to lose some of the aggressive thinking and planning that has dramatically defined the differences between large and small in this business.

The venture groups, meanwhile, are all sounding suitably bullish. If investors keep jumping into new funds, there will be more money available for players--particularly in the U.S.

Related Articles:
Billion-dollar baby: Biotech still on a roll with VC funds. Report
Deal-making hits a faster pace in '07. Report
Burrill bullish on M&As. Report
Should Pharma take the M&A cure? Report
M&A activity heats up as biotech IPOs struggle. Report

2007: A year in review

Fri, 21 Dec 2007 06:59:59 -0500

Loyal readers of FierceBiotech are well aware of just how big a year the industry has just posted. Deals were up as new licensing pacts, venture rounds and mergers dominated the news. The restructuring of Big Pharma focused a spotlight on the emerging role of biotechnology in the discovery of important new therapies. Asia and Europe took steps to play a leading role in pipeline work. And scientists the world over made significant strides in often controversial fields.

The globalization of biotechnology and the increasing importance of biologics in drug discovery are not short-term phenomena. These are trends that will continue to dominate an industry that is moving steadily in a new direction. And we'll be here in 2008 to chronicle it all.

Which makes this a good time to take a break. We'll be back on January 2 to pick up where we left off. Nearly 100,000 subscribers around the world have signed up for FierceBiotech, FiercePharma, FierceBioResearcher and our new pub, FierceVaccines. And we're expecting another notable year in '08. - John Carroll

Investors: Biologics are 'hot' right now

Tue, 04 Dec 2007 06:59:57 -0500

Kate Bingham, managing partner at SV Life Sciences, says that biologics are "hot" right now for investors. Speaking at a European conference, Bingham said that deal-making and greater innovation were driving the growth of the continent's biotech sector. "Innovation is being concentrated on drugs being prescribed by specialists in hospitals," she told the group, with antibodies also attracting a lot of attention.

- read the report from AFX

Related Articles:
MAbs are hottest segment of biotech industry. Report
Sanofi: We're looking for biotech deals. Report
Pfizer's future rests with biotech. Report
Lines blur as Big Pharma crosses borders into biotech. Report

Sanofi: We're looking for biotech deals

Fri, 30 Nov 2007 06:59:58 -0500

Following yesterday's investment in Regeneron, Sanofi-Aventis' Marc Cluzel (photo) reiterated the company's plans to aggressively pursue biotech buyouts. "If there is a good deal to be done, we will do it. We are very pragmatic," Cluzel told investors. Currently, only 10 percent of the drugs Sanofi makes are biologics; the company wants to boost that number to 20 or 30 percent by 2012.

Sanofi isn't the only big pharma that has shifted its focus to biotech. Pfizer has been on a year-long crusade to expand its biotech efforts, and AstraZeneca formed a massive biotech unit when it united Cambridge Antibody Technologies with MedImmune to form a biotech powerhouse. As more big developers fill their pipelines with biologics, competition for the most promising biotech drugs is going to get tough.

- see this report for more

Related Articles:
Lines blur as Big Pharma crosses borders into biotech. Report
Sanofi snags bigger stake, new pact with Regeneron. Report
Sanofi underscores pipeline advances, setbacks. Report

Astellas inks $537M deal for Agensys

Tue, 27 Nov 2007 06:59:58 -0500

Japan's Astellas has forged a deal to buy Santa Monica, CA-based Agensys for $387 million plus up to $150 million more in milestones. The deal gives Astellas new antibody technology for combating cancer. Agensys has a Phase Ib trial underway for one antibody plus several more preclinical candidates. Astellas is betting that antibodies will play an ever-growing role in cancer treatments, which are expected to command a $32 billion market by 2015.

"Agensys will be the cornerstone of our biologics efforts and an integral component of building our oncology efforts within our franchise," explained Masafumi Nogimori, CEO of Astellas.

- see this release for more
- check out the report on the deal

Related Articles:
Astellas faces FDA delay on reformulated Prograf. Report
Cardiome, Astellas get panel date. Report
Agensys gains $41M in venture funds. Report

Zosano rounds up $45M in VC

Fri, 16 Nov 2007 06:59:57 -0500

Fremont, CA-based Zosano Pharma has received $45 million in its second round, bringing its total funding thus far to $90 million. Enterprise Associates, Nomura Phase4 Ventures, HBM BioVentures and ProQuest Investments participated in the round. Zosano is developing a transdermal microprojection delivery system, a small patch and applicator that is designed as an alternative to vaccines administered with needles.

"This second closing supports our continued progress with Zosano's lead program, a PTH patch for treating osteoporosis, which is currently in Phase 2 development," said Cory Zwerling, Zosano's CEO. "Our PTH development program is on track and we are also moving other Zosano activities forward."

- see this release for more

PLUS: Woburn-MA-based BioVex has garnered $35 million in a second round of Series E financing. The company is developing biologics for the treatment and prevention of cancer and infectious disease. The money will fund BioVex's Phase III study of OncoVexGM-CSF for the treatment of melanoma as well as to complete studies in head and neck cancer and pancreatic cancer. Triathlon Medical Ventures led the round. Release

Related Articles:
BioVex raises $22M for ongoing cancer trial. Report
BioVex moving HQ to Mass. Report

Forget CAT: the name is MedImmune now

Mon, 29 Oct 2007 07:59:56 -0400

AstraZeneca has taken another big step in its plan to create a major new biologics company under the MedImmune name. Cambridge Antibody Technology has been renamed MedImmune as AstraZeneca concentrates its biotech activity under one corporate banner with $1.3 billion in revenue.

John Stageman, Ph.D., vice president of AstraZeneca biopharmaceutical strategic planning, assumes the role of interim site head in Cambridge. "AstraZeneca's biologics capabilities have been enhanced significantly by the acquisitions of CAT and MedImmune to create a more robust, highly competitive and fully integrated biotechnology business," says Stageman. The British press, though, has made it clear that there are quite a few people at CAT who believe that AstraZeneca's move amounts to a stab in the back.

- check out the release for more

Related Articles:
AstraZeneca merges MedImmune, CAT. Report
CAT fetches $1.3B in AstraZeneca buyout. Report
AstraZeneca snares MedImmune in $15.6B buyout. Report
AstraZeneca lays out road map for recovery. Report
Top five layoffs of 2007--AstraZeneca. Report

SPOTLIGHT: EU biosimilars market opens up

Thu, 25 Oct 2007 06:59:53 -0400

The Chicago Tribune looks at Europe's new market for follow-on biologics as U.S. generics companies are still waiting on new legislation. Report