BioSpace BioPharm Exec
Wednesday, September 26, 2012
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Pharma Embraces Emerging Markets; They Don't Embrace Back
Plus a Modest Patent Proposal

Like most major pharma companies, Novartis has been looking to emerging markets to help shore up the revenue gap created by patent expirations. China, India, and other emerging economies represent not just a source of cheaper R&D and manufacturing, but millions of new--and newly affluent--customers. The theory is that the rising middle class and new government assistance programs in these nations will be enough to bolster sales while new pipeline products advance. More...

More By Karl Thiel

Dengue fever is a mosquito-borne virus that has long eluded the efforts of researchers to create vaccine...despite the fact that it is related to yellow fever and Japanese encephalitis, both of which are well controlled by vaccines. And it is a huge problem, with a 30-fold jump in Dengue cases in the last half century and 50 million to 100 million people infected each year. Sanofi's Dengue fever vax, for which it had high hopes and a target market of over $1 billion, appeared to work reasonably well (60% to 90% protective) against 3 of 4 Dengue strains. Unfortunately, it was the fourth strain that was prevalent in Thailand at the time the study was conducted there. That brought overall efficacy down to about 30% and dashed hopes of an early filing. Two large phase 3 studies are still underway.

Dengue is also related to West Nile virus, incidentally, which is becoming a significant problem outside the tropics. Let's hope those vaccine efforts prove easier.

Roche, meanwhile, is getting more aggressive about its Alzheimer's drug gantenerumab, more than doubling the size of a phase 3 study that began in 2010. Gantenerumab is similar to failed drugs from Eli Lilly and Pfizer/Johnson & Johnson in that they all are monoclonal antibodies that bind to beta-amyloid plaques. The key difference is that Roche is studying patients who have not yet shown signs of dementia. It may be that this class of drugs can help delay onset of dementia but cannot reverse it once it begins. Here's hoping. -KT
Pfizer Inc. (PFE)'s RA Drug Tofacitinib Tops Methotrexate in Phase III
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Threshold Pharmaceuticals, Inc. (THLD) Plummets on Pancreatic Cancer Drug Study Survival Results
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Sanofi (France) (SAN.PA) Dengue Vaccine Less Effective Than Hoped
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Roche (RHHBY) Ramps Up Alzheimer's Drug Trial as Rivals Stumble
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Merck & Co., Inc. (MRK) Insomnia Drug Shows Positive Phase III Results
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More Bench To Clinic News
Pascal Soriot has been Roche's chief operating officer for the past couple years, but starting October 1, he'll be running AstraZeneca. The corner office has been vacant since June, when prior chief executive David Brennan abruptly left following criticism from shareholders. Some analysts have suggested he'll be more inclined to deals, especially around biologics, than his predecessor.

Roche, meanwhile, has finally settled on a location for the R&D facility that will house at least some workers from its shuttered Nutley, N.J. campus. It's not far away--just over in Manhattan. That will save about 200 jobs, but the company's cost-cutting effort will end up axing about 1,000 jobs altogether. -KT
Roche (RHHBY) Picks NYC for New R&D Site
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AstraZeneca PLC (AZN) Grabs Roche (RHHBY) Pharma Head as New CEO
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Johnson & Johnson (JNJ) Starts 4 Innovation Centers to Scope for Early-Stage Acquisitions, Licensing Deals
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Merck KGaA (MKGAF.PK) to Axe 1,100 Jobs in Germany
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Teva Pharmaceutical Industries Limited (TEVA) Chair Should Fly Business Class: Shareholder
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More Career Track News
The Life Sciences Report Analyst Bets on Extraordinary Science and Clinical Data: Greg Wade
By George S. Mack of The Life Sciences Report

Managing Director Greg Wade of Wedbush Securities doesn't use a cookie-cutter approach to picking biotechnology stocks. He directs investors to companies with strong science, well-executed clinical studies and data that points toward future success. More...
The Life Sciences Report Think Long Term and Win Big With Small Biotechs: Hugh Cleland
By George S. Mack of The Life Sciences Report

BluMont Capital Portfolio Manager Hugh Cleland has taken a venture capital and private equity approach to investing in public companies, some of which have penny-stock market caps in the $5-$15 million range. The idea is to invest in small- and micro-cap stocks without facing redemption risk, and to More...
Servier is hot for Macrogenics' DART (dual-affinity retargeting) antibody technology: Following up on a December 2011 agreement for a phase 1 anti-cancer compound, the companies have now formed an option agreement covering three preclinical DART compounds, with Macrogenics maintaining rights in North America, Japan, India, and Korea. The companies will share development costs if Servier exercises its option.

Baxter snapped up European rights to Onconova's Estybon, in late-stage development for myelodysplastic syndromes. And MedImmune is expanding its reach into China through a joint venture. Its partner, WuXi AppTech, gets to build out its expertise in guiding MED15117, for rheumatoid arthritis, through development, manufacturing, and approval in China. That's not the only significant joint venture formed this month--both Merck and Pfizer formed JVs with Chinese companies to promote branded generics. -KT
Baxter International, Inc. (BAX) and Onconova Therapeutics Inc. Announce European Licensing Agreement for Up to $515 Million
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MacroGenics, Inc. Could Earn More Than $1 Billion Through New Servier Alliance
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AstraZeneca PLC (AZN)'s MedImmune (AZN) Forms Chinese Joint Venture for Biologic Drug
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Complete Genomics, Inc. to be Bought by Chinese Firm for $117.6 Million
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Genmab A/S (GEN.CO) Inks $1.1 Billion Deal With Johnson & Johnson (JNJ)
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More Golden Handshakes News

Top Jobs
• Rocky Mountain (Albuquerque, New Mexico)

IntelliCyt Corporation
Vice President, Marketing
He/She will be responsible for providing executive leadership and management of the Company's marketing organization and inbound and out-bound marketing activities worldwide, which include: corporate marketing, partner/channel marketing, product marketing, product management, and corporate business development. Will drive the Company's efforts to position itself as a visionary leader and potential in its emerging market and to achieve its revenue goals.

• BioChina (Jinan, Shandong)

KBP BioSciences Co., Ltd.
Vice President/Senior Director of Toxicology
Selected candidate will be responsible to develop preclinical safety plans and protocols and manage external partners to complete studies according to the plans and protocols. As the leader of the toxicology center, this individual will draft and implement SOPs to ensure compliance with internal and external policy and regulations. Also as a development project team leader, he/she will provide scientific leadership to move projects forward. He/she will participate in IND filing and provide expert opinions at meetings and discussion with external panels and experts.

• Pharm Country (Basking Ridge, New Jersey)

Ipsen
VP & Chief Medical Officer
Will be responsible for providing strategic direction and leadership for drug safety, local medical affairs operations, commercial regulatory affairs, biostats as well as the medical affairs teams for both the Endo and the Neuro business areas. In this capacity the position will design near and long term strategies and tactics that will protect and optimize the companies' products. The position will determine post approval clinical work that needs to be done, will oversee the ESS and Medical Grant process, will ensure that state of the art commercial regulatory support is provided and that all safety reporting obligation are met in a timely and effective manner.

• BioMidwest (Twin Cities Area, Minnesota)

Setren, Smallberg & Associates, Inc.
Chief Commercial Officer
This individual will provide strategic leadership to define and implement the sales strategy across the U.S. and international markets, particularly Europe, Australasia and India. The Chief Commercial Officer will establish the marketing and sales infrastructure for the Company in the U.S. and international markets. He/she will lead the Functional areas of Marketing Operations, Market Strategy, Sales Strategy, Operations and Reimbursement, Product Management, Key Partnership Marking, Customer Service and Retention.

Get Noticed! Add your resume to the BioSpace Career Center!
See more than 5,000 job postings in the BioSpace Career Center!

Biotech Bay Career Fair Biotech Bay Career Fair
San Francisco Airport Marriot, Wednesday, October 3, 2012, 1pm to 6pm. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Bay area.
BioCapital Career Fair BioCapital Career Fair
Bethesda North Marriott & Conference Center, Tuesday, October 9, 2012, 11am - 4pm Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Mid-Atlantic region.
Talk about a quick exit! Selexys raised $23 million in a Series A round and entered a simultaneous option agreement with Novartis that will let the pharma giant acquire the company if its lead compound succeeds in phase 2. If all goes well, it will be a relatively quick moneymaker for Selexys management and its backers (including MPM Capital). But it certainly limits the upside. If things don't go smoothly, well...Selexys remains independent, but it may find it difficult to raise more money. In Vivo points outpoints out that there are other examples of this kind of option agreement, but they certainly aren't common...at least yet. -KT
Selexys Pharmaceuticals Corporation Completes $23 Million Equity Financing and Signs Agreement With Novartis Pharmaceuticals Corporation (NVS) for Up to $665 Million
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Startup Heart Drug Developer MyoKardia Lands $38 Million
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Google Inc. Venture Fund Eyes Biotech Start-Ups With $1 Billion in Pocket
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Foundation Medicine Announces $42.5 Million Series B Financing
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Intercept Pharmaceuticals Files for $75 Million IPO
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More Money Talk News

Novartis' appeal over a new patent for Glivec isn't the only issue the Indian courts are weighing. They were also asked to decide whether Cipla infringed a Roche patent when it made a knock-off of Tarceva. The court came down on the side of the homegrown generic industry. Meanwhile, KV Pharmaceutical--surprise, surprise--lost its suit against FDA over Makena enforcement. And Johnson & Johnson has settled its Risperdal promotional lawsuits--and avoided having CEO Alex Gorsky forced to testify in the case of a 17-year-old boy whose family said he grew breasts after taking the drug. -KT
Johnson & Johnson (JNJ) CEO Dodges Bullet in Risperdal Drug Case
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Johnson & Johnson (JNJ) Settles Risperdal Side Effect Lawsuit
More...

Use of Gilead Sciences, Inc. (GILD) Stribild HIV Pill May be Limited in U.S.
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India Court Rules for Cipla Ltd. Against Roche (RHHBY) in Patent Case
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Johnson & Johnson (JNJ) Gets Multiple Subpoenas Regarding McNeil Consumer Healthcare's Product Recalls
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More Legal Briefs News
Teva gained more success in the follow-on biologic market with the approval of its version of Amgen's Neupogen. It's worth noting this is not an identical, substitutable drug but rather a biosimilar that will have to fight for market share (in Europe, where it is already sold, it has about 5%). Nevertheless, the sooner-than-expected approval is a sign that FDA is becoming more comfortable with similars and with weighing them up on a case-by-case basis. (Teva still claims for its own part that the slightest change to the manufacture of its multiple sclerosis drug Copaxone can render it unsafe or even deadly).

Pfizer's Bosulif, meanwhile, is a new molecular entity for chronic myelogenous leukemia that will compete with Novartis' Gleevec. It is the company's second oncology NME to be approved this year, after the kidney cancer drug Inlyta. Bosulif is expected to have peak sales of around $350 million. -KT
Johnson & Johnson (JNJ)'s Janssen Biotech Inc. Unit Submits BLA for Anti-TNF)-alpha SIMPONI
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Sanofi (France) (SAN.PA)'s Genzyme Corporation (GENZ) Wins FDA Approval for Multiple Sclerosis Pill
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Amarin Corporation PLC (AMRN) Still Awaits FDA OK for Heart Drug
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FDA Approves Pfizer Inc. (PFE)'s Leukemia Drug
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FDA Approves Teva Pharmaceutical Industries Limited (TEVA) Copycat of Amgen (AMGN)'s Neupogen
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More Rockville Files News

Karl Thiel is an analyst for The Motley Fool, a columnist for BioWorld Today, and a contributor to Nature Biotechnology. He lives in Portland, Oregon.

You may contact Karl Thiel at Karl.thiel@biospace.com.

BioSpace, Inc.
6465 South Greenwood Plaza, Suite 400
Centennial, Colorado 80111 U.S.A.
Phone: 877-277-7585
Fax: 800-595-2929
BioSpace, Inc.
90 New Montgomery Street, Suite 414
San Francisco, California 94105 U.S.A.
Phone: 877-277-7585
Fax: 415-576-9217



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