PharmaLive.com, September 22, 2010 — During 2009, total worldwide pharmaceutical sales increased 27.9% to $732.9 billion. Biotechnology companies in the U.S., Europe, Canada, and Australia had a combined net profit of $3.7 billion in 2009, a vast improvement from the $1.8 billion net loss in 2008. This performance is impressive considering the overall economic and unique healthcare-market challenges these industries have faced in recent years.

Pharma expanding its biologic footprint to remain competitive

Pharmaceutical companies are continuing to look toward biotechnology companies and products to sustain them moving forward. Through its acquisition of Genentech, Roche is expanding its footprint in personalized medicine. And Pfizer, with the acquisition of Wyeth, has increased research emphasis on biotherapeutics and vaccines. As of January 2010, Pfizer had 133 products in development, including 27 biologics and six vaccines, up from 16 biologics and one vaccine a year earlier.

Major healthcare companies are making biologic and biosimilar development a priority. Merck & Co., which recently merged with Schering-Plough, has made biosimilars the focus of MerckBioVentures, a division created in December 2008. Following the company’s recent portfolio prioritization, Merck has five novel biologics and two biosimilar candidates in clinical development.

Reform’s impact on partnerships & research

New healthcare reform laws are expected to cost drug manufacturers hundreds of millions of dollars in the short term, but will even out as marketers gain access to a wider patient pool. Overall, industry leaders are pleased with the reform’s provisions for biosimilars, 12-year patent exclusivity, and tax credits for innovation.

The healthcare reform bill also includes the incentives necessary to attract the major investment required for the discovery and development of novel products. To offset the competition of biosimilars, biotech companies are expected to fill their pipelines with next-generation, break-through biologics as they look for ways to differentiate their portfolios.

Personalized medicine has become a significant area for companies within the pharma and diagnostic industries. The $232 billion personalized medicine market in the U.S. is projected to grow 11% annually over the next several years. Industry experts estimate that orphan drugs bring in about $40 billion in annual sales and that figure will continue to grow as more large pharma and biotech companies focus on orphan drug development.

Ferring is a Swiss-headquartered, research driven, speciality biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of urology, endocrinology, gastroenterology, gynaecology, and fertility. In recent years Ferring has expanded beyond its traditional European base and now has offices in over 40 countries. Over the past two decades Ferring has on average maintained an annual growth rate of 15 percent.

Extension study with FIRMAGON® (degarelix) showed continued benefits for prostate cancer patients beyond one year

Data recently presented on FIRMAGON® (degarelix) hormonal therapy for prostate cancer showed that long-term use beyond one year (median observation time 840 days) continued to be effective and well tolerated.1 Full details were shared at the American Urological Association (AUA) 2010 Annual Meeting.

FIRMAGON® is a gonadotropin-releasing hormone (GnRH) receptor blocker indicated for the treatment of patients with advanced hormone-dependent prostate cancer. The Phase III extension study beyond one year (CS21A) of the pivotal FIRMAGON® vs leuprolide trial (CS21) was designed to collect extended safety and tolerability data on FIRMAGON®. At the end of the CS21 one-year trial, all patients were offered to continue treatment with FIRMAGON®, both those originally on FIRMAGON® and those who had used leuprolide (a GnRH agonist).

The main findings were:

  • Efficacy of FIRMAGON® was maintained over the full study period (median observation time 840 days)1
    • In the intent-to-treat (ITT) study population, FIRMAGON® significantly improved prostate specific antigen (PSA) progression-free survival (PFS) compared with leuprolide during the first year of therapy. The leuprolide patients, who continued treatment with FIRMAGON®, experienced a significantly lower event rate leading to an improved PSA PFS.1
  • Tolerability of FIRMAGON® was maintained throughout the extended study period.1

“These data reassure physicians that for the best outcomes when using FIRMAGON® as a therapy for hormone dependent prostate cancer, patients should start and stay on FIRMAGON®,” said Dr E. David Crawford, head of Urologic Oncology, University of Colorado, Denver Health Sciences Center, and Practice Director for the Urologic Oncology Clinic. “FIRMAGON® provides a fast and sustained reduction in testosterone levels and these new data indicate that efficacy is maintained over the long-term without any additional negative effects on tolerability.”

Although the extension trial was not specifically designed to test changing from leuprolide to FIRMAGON® after one year, the results suggest that changing from leuprolide to FIRMAGON® improves PSA PFS.1

Additional analysis of the safety data from the pivotal Phase III trial were also presented at AUA. The analysis evaluated the cardiovascular safety profile of FIRMAGON® vs leuprolide. The results showed that there were no significant differences between the cardiovascular safety profile of the two treatment groups, and the risk of CV events in both treatment arms was low.2

  • Mean changes in QTcF interval were similar for FIRMAGON® and leuprolide.
  • Rates of CV adverse events were low and similar for FIRMAGON® and leuprolide.

Latest Key Developments

Celera Genomics, an Applera Corp. Signs Agreement With Abbott Laboratories For Distribution Of CE-marked KIF6 Test To Identify Patients At Risk of Coronary Heart Disease


Monday, 20 Sep 2010 07:00am EDT

Celera Genomics, an Applera Corp. and Abbott Laboratories announced that they have signed an exclusive distribution agreement to market Celera’s CE-marked KIF6 diagnostic test for use on Abbott`s CE-marked m2000 instrument system. The KIF6 genotyping assay detects a genetic marker that may be used in conjunction with clinical evaluation and patient assessment for the identification of individuals at risk for coronary heart disease (CHD), and in patients for whom statin treatment is being considered. The agreement follows the application by Celera for the CE mark in June 2010, of its real-time PCR (polymerase chain reaction) test for detection of a variant in the KIF6 gene. This is the first of Celera`s cardiovascular genetics products to be CE marked. Under the four year agreement, Celera will manufacture the KIF6 test kit that Abbott will distribute in the European Union, other geographic areas that recognize the CE mark, and elsewhere worldwide, excluding the U.S. Financial details of the agreement were not disclosed.

Abbott Laboratories Announces Quarterly Dividend


Thursday, 16 Sep 2010 12:05pm EDT

Abbott Laboratories announced that it has declared a quarterly common dividend of $0.44 per share. The cash dividend is payable on November 15, 2010, to shareholders of record at the close of business on October 15, 2010.

Abbott Laboratories Completes Acquisition Of Piramal Healthcare Limited’s Healthcare Solutions Business


Wednesday, 8 Sep 2010 02:45am EDT

Abbott Laboratories announced that it has completed its acquisition of Piramal Healthcare Limited’s Healthcare Solutions business. Piramal Healthcare Limited ‘s Healthcare Solutions business has a portfolio of branded generics, including brands in multiple therapeutic areas, including antibiotics, respiratory, cardiovascular, pain and neuroscience. The Healthcare Solutions business will operate as a separate business unit, reporting into Abbott Laboratories’ newly-created Established Products Division. The business will continue to be led by its current India-based management team. Abbott Laboratories, through a wholly-owned subsidiary, purchased the assets of Piramal Healthcare Limited’s Healthcare Solutions business for a $2.2 billion up-front payment with additional payments of $400 million annually for the next four years, beginning in 2011.

Abbott Laboratories Receives FDA Approval for Automated Molecular Test for Assessing Hepatitis B Treatment


Wednesday, 1 Sep 2010 10:05am EDT

Abbott Laboratories announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market the Abbott RealTi m e HBV assay for measuring viral load or the amount of hepatitis B virus (HBV) in a patient’s blood. It is the first and only approved test capable of automating HBV viral load testing from sample extraction to final results

Drug Development

FDA Approves Novartis Multiple Sclerosis Drug

The Food and Drug Administration approves orally administered multiple sclerosis drug Gilenya.

FORBES.com, September 22, 2010 — Novartis said today that the U.S. Food & Drug Administration has approved its orally administered multiple sclerosis drug Gilenya, the first oral treatment for the drug to be approved here.

The drug stems M.S. relapses and slows progress of the physical problems the disease creates. Prior to Gilenya, only injectable treatments were approved,
FDA Approves Tekamlo
Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure

EAST HANOVER, N.J., Aug. 27 /PRNewswire/ — The US Food and Drug Administration (FDA) approved Tekamlo (aliskiren and amlodipine) tablets, a single-pill for the treatment of high blood pressure combining the only approved direct renin inhibitor, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine. Tekamlo is approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals, and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone.

“We welcome the FDA’s decision to approve Tekamlo, as the treatment of high blood pressure remains a challenge for many patients, requiring multiple medications to control their condition,” said David Epstein, Division Head of Novartis Pharmaceuticals. “This approval reinforces Novartis’ commitment to cardiovascular research and to developing innovative and effective treatments for patients who have not reached their blood pressure goal.”

The FDA approval of Tekamlo was based on clinical trial data involving more than 5,000 patients with mild-to-moderate high blood pressure. An eight-week, randomized, double-blind, placebo-controlled, multi-factorial study showed that the combination of Tekturna and amlodipine resulted in decreases in systolic/diastolic blood pressure at trough of 14-17/9-11 mmHg, compared to 4-9/3-4 mmHg for Tekturna alone, and 9-14/6-8 mmHg for amlodipine alone.

In two additional double-blind, active-controlled studies of similar design evaluating patients with moderate-to-severe high blood pressure (SBP 160 – 200 mmHg), Tekamlo demonstrated significantly greater reductions in systolic and diastolic blood pressures when compared to amlodipine alone. In one study of 443 Black patients, the systolic/diastolic treatment difference between Tekamlo and amlodipine was 5.2/3.8 mmHg at the primary endpoint of eight weeks. In the other study of 484 patients, the treatment difference between Tekamlo and amlodipine was 7.1/3.8 mmHg at endpoint.
Novartis and Hypertension Management
For decades Novartis has been a leader and innovator in hypertension management, offering a range of innovative therapies designed to help patients with different needs achieve their blood pressure goals. Novartis is dedicated to helping physicians and patients improve cardiovascular and metabolic health through effective medicines, programs and an ongoing commitment to research.

Tekamlo is available in four strengths as once-daily tablets containing aliskiren and amlodipine: 150 mg/5 mg tablets, 150 mg/10 mg tablets, 300 mg/5 mg tablets and 300 mg/10 mg tablets.

Read more: http://www.drugs.com/newdrugs/novartis-receives-fda-approval-tekamlo-single-pill-combination-aliskiren-amlodipine-blood-pressure-2259.html#ixzz10Il6DozM

Lilly Recognized with World Business and Development Award for Tuberculosis Initiative
Lilly Honored for Contribution to Millennium Development Goals by the International Chamber of Commerce, United Nations Development Program and International Business Leaders Forum
NEW YORK, Sept 21, 2010 /PRNewswire via COMTEX News Network/ — An eminent international panel of judges has selected Eli Lilly and Company (NYSE: LLY) to receive a World Business and Development Award for demonstrating what can be achieved through successful partnerships in the battle against multidrug-resistant tuberculosis (MDR-TB).

Lilly was chosen because the activities of The Lilly MDR-TB Partnership demonstrate a clear linkage between vital business practices and a contribution toward achieving the United Nations Millennium Development Goals (MDG). The MDGs, endorsed by 189 countries, include eight goals that promote the reduction of poverty, better education, improved maternal health, gender equality, the lessening of child mortality and the eradication of infectious diseases, including tuberculosis.

“We are extremely honored and grateful for this recognition, just as we are inspired daily by the dedication of the organizations and individuals who are part of The Lilly MDR-TB Partnership. We all know how much work remains to be done, but we believe that over time we can make a tangible difference in stamping out a disease that takes so many millions of lives,” said Jacques Tapiero, president of emerging markets for Lilly.

The World Business and Development Awards, given every two years, showcase the creative efforts of the private sector in applying their core business expertise to helping achieve the goals. Winners of past awards, together, have improved the lives of millions of poor people throughout the world.

By collaborating with international and non-profit organizations, governments and civil society, Lilly has proven that private companies can make enormous strides in helping the international community achieve the MDGs. Over a very short time, the Partnership has produced real accomplishments despite significant obstacles and continues to build on lessons learned in achieving even more. Among Lilly’s efforts has been the transfer of drug-making technology and expertise to companies in China, India, Russia, South Africa and elsewhere.

The Lilly MDR-TB Partnership was created to confront a disease so daunting that no single organization could fight it alone. Working in over 80 nations and with more than 20 partners, The Lilly MDR-TB Partnership has trained doctors and nurses to recognize, treat, monitor and prevent the spread of multidrug-resistant tuberculosis. They have raised awareness to de-stigmatize the disease, promoted prevention, researched drugs, improved treatment and advocated for some of the most vulnerable people in the world. Efforts are tailored to the needs of the individual nation and region.

About two billion people around the globe are infected with latent TB. Nearly two million people die each year — 4,500 each day — from a disease that is curable for those with access to care. Multidrug-resistant TB now strikes at least a half million people every year and, experts say, every person with MDR-TB may unknowingly infect up to 20 others, including their own family.

Introduced by the International Chamber of Commerce (ICC), the awards have become increasingly successful each year since they began in 2000. In 2004, the United Nations Development Programme (UNDP) and the International Business Leaders Forum (IBLF) joined with ICC to organize the awards. The true spirit of the awards lies in the recognition of productive and innovative business-driven solutions to sustainable development.

The United Nations has devoted the year 2010 to building a renewed momentum around the MDGs, which have a deadline of 2015. This year, special attention is focused on the role of business in development through an initiative known as the Business Call to Action. The 2010 World Business and Development Awards is one of the central events recognizing the many contributions of the private sector to sustainable development.

This year’s award recipients will receive their official honors at the United Nations in New York at 6pm ET on September 21, 2010, concurrent with a special MDG summit hosted by the UN Secretary-General.

About The Lilly MDR-TB Partnership

The Lilly MDR-TB Partnership was created to confront multidrug-resistant tuberculosis. Since 2003, the public private initiative, mobilizing over 20 partners on five continents, has worked together to share expertise in the quest to contain and conquer one of the world’s oldest diseases. The Lilly MDR-TB Partnership is funded by Eli Lilly and Company. www.LillyMDR-TB.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. Additional information about Lilly is available at www.lilly.com. CR-LLY

Pfizer Brings More than Drugs to Rwanda

Posted by Josh Ruxin

When donors want to strengthen the health care system in a developing country, most think more is always better: more money, more equipment, more medicines and supplies. Management training is often an afterthought, even though the clever and experienced administration of limited resources can be exponentially more effective than the poor management of plenty. While no one is against more resources for health for poor people, pouring money into health care can do little or no good if the health system lacks a strong foundation: A solid business model, staff with operational as well as clinical skills, and leaders who understand that well-managed, well-organized health centers are a prerequisite for better health.

A solid business model demands strong business skills—something usually lacking in developing countries. Pharmaceutical giant Pfizer is one of the few multinational corporations—maybe the only one in health—that has recognized that its staff’s management skills can be as valuable as the medicines they develop. Pfizer’s Global Health Fellows program has, since 2003, sent scores of Pfizer employees around the globe for three to six-month volunteer engagements with NGOs working at the front lines of health care in developing countries. Pfizer fellows come from all over the company and bring a variety of skills—from finance and statistics to business strategy and communications—that they then transfer to staff members of non-profits who work to bring health care to the poorest of the poor.

All this is not to say that financing for critically needed medicines and infrastructure isn’t vital. Nevertheless, human capital is just as important. Bringing skilled, business-minded people like Gabriel to developing countries will help create long-lasting change that helps health systems make the best use limited resources as they address the staggering constellation of public health challenges in Africa.

Mergers and Acquisitions

J&J Close To Buying Crucell For $2.3 Billion

FORBES.com, September 22, 2010, by Carl Gutierriz — The heath care conglomerate says it’s close to purchasing the Dutch biopharmaceutical firm in an effort to enhance its vaccine platform.

Health care conglomerate Johnson & Johnson announced Friday that it’s in advanced talks to acquire Dutch biopharmaceutical firm Crucell for approximately $2.3 billion in an effort to bulk up its vaccine platform.

Johnson & Johnson ( JNJnews people ), which already owns 17.9% of Crucell through an affiliate, says that under terms of the negotiations, which are in “an advanced stage,” J&J or an affiliate would acquire all remaining shares of Crucell that it does not already own for about 1.75 billion euro, or $2.3 billion, in an all cash transaction.

J&J expects Crucell will create a strong platform in the vaccine market (See “Strange Days For Blue Chips.”), and said the deal would enable the Dutch firm to benefit from the larger organization’s expertise and experience in the development and commercialization of pharmaceutical products.

After closing the deal, J&J expects to maintain Crucell’s existing facilities, retain senior management and “generally” keep current employment levels. J&J also said it intends to keep Crucell as the center for vaccines within its pharmaceutical group.

September 22, 2010

Economic Model Presented At TCT 2010 Suggests That the Use of CYPHER Drug Eluting Stent May Result In Substantial Cost Savings When Compared To Other Drug Eluting Stents

September 21, 2010

The GRACE study has significant implications for inclusion of women in clinical trials

U.S.Equities
Forest Labs Reports Positive Findings

FORBES.com, September 22, 2010 — Ironwood Pharmaceuticals and Forest Laboratories said late Monday a Phase 3 clinical trial of the irritable bowel drug linaclotide showed positive results.

Analysis of the data for the use of the drug in patients with irritable bowel syndrome with constipation shoed statistically significant improvement in four primary endpoints compared to a placebo.

The companies have a second Phase 3 trial ongoing, with results expected in the fourth quarter.

Five Stock Picks For September By Forbes China

FORBES.com, September 22, 2010, By RUSSELL FLANNERY

Investing in China’s healthcare- and pharmaceutical-related industries is an idea with seemingly great promise. Rising incomes and demographic trends suggest growing demand for services and spending for years to come. Big multinationals like Pfizer, Novartis and Johnson & Johnson are already active in China.

Those two industries were selected in September for a stock investment report by ForbesChina.com, the licensed Chinese-language online edition of Forbes. Working with the U.S.-based Applied Finance Group, ForbesChina.com published a list of five domestically traded stocks that were considered undervalued based on their price on Sept. 3.

Since the orginal article was published earlier this month at ForbesChina.com, some of that valuation gap has closed, or in the case of one, disappeared. Yet the companies might still be worth keeping an eye on.

*Shanghai Kehua Bio-engineering (002022), a developer and producer of in vitro diagnostic products, has 400 distributors in China and 22 overseas. ForbesChina.com said the closing price of 16.9 yuan on Sept. 3 carried a 10% discount relative to its investment value. The company is a supplier to the World Health Organization.

*Joincare Medical (600380), a maker of gynecological products, was trading a discount of 22% on Sept. 3, according to ForbesChina.com. The company is controlled by Zhu Baoguo, who ranked at no. 83 on our list of China’s richest people last year with wealth of $945 million. As of Sept. 3, the stock was trading at a discount of 10% to its value of 12.8 yuan.

*Shandong Dong-E E-Jiao (000423) supplies traditional Chinese medicine products. At its Sept. 3 closing price of 42.33 yuan, it was trading at a discount of 12% relative to its actual value.

*Changchun High & New Technology (000661) invests in pharmaceuticals and traditional Chinese medicine suppliers, among other businesses. Its stock price of 9.19 yuan on Sept. 3 was undervalued by 14%, ForbesChina.com said.

*Shandong Lukang Pharmaceutical (600789) manufactures antibiotics. As of Sept. 3, the stock price of 9.19 yuan was 14% undervalued relative to its investment value, ForbesChina.com said.

For the original version of this article by ForbesChina.com, please see:
http://www.forbeschina.com/review/201009/0003705.shtml