DMS Plans Second Distributions Facility in Ohio

   The Midwest pharmaceuticals supplier is scouting locations for a second warehouse/distributions center as part of its long-term expansion plan.

   "With our client account base continuing to grow, DMS now serves customers from all corners of the U.S. Therefore, we are constantly exploring how we can provide them with the best possible turnaround and fill rates," states Sam Lazich, DMS president.

   The proposed Ohio center will facilitate inventory buildup and deliveries for major contractual accounts, including government and hospital organizations.

Avastin, Lucentis Boost
Genetech Drug Sales

Continuing strong cancer drug Avastin use
and the new eye-disorder treatment Lucentis get credit

  Avastin is used increasingly in lung cancer patients. This drug is also prescribed for colorectal cancer.

  Lucentis is a drug approved in 2006 for treatment of wet, age-related macular degeneration (AMD). This degeneration is the leading cause of blindness in the elderly.

Caraco Announces Tentative
FDA Approval for Generic Provigil

  Caraco Pharmaceutical Laboratories, Ltd. announced the FDA has granted tentative approval for the company's Abbreviated New Drug Application  for Modafinil Tablets (modafinil), 100mg and 200mg.

  Modafinil prescribed to improve wakefulness in patients with excessive sleepiness associated with narcolepsy. This new product is the bioequivalent to Provigil, a registered trademark of Cephalon, Inc.

  Caraco's Chief Executive Officer, said, "We are extremely pleased to receive this tentative approval. Modafinil was filed with a paragraph IV certification that we do not infringe and or that the Cephalon patent is invalid. We were not sued by Cephalon. We looked forward to marketing this product subsequent to the expiration of the patent and exclusivity period."

Abbott and Abbott Fund Increase
Commitment to Fight Pediatric HIV/AIDS
in Africa with $12 Million in New Support

  Abbott and Abbott Fund announced several efforts to expand access to treatment and care for children living with HIV/AIDS. This new support includes additional investment of $12 million in grants and product donations this year.

  These programs will work to close some of the gaps in pediatric HIV care by increasing the number of trained, experienced pediatric HIV doctors and health care workers; establishing critical linkages between prevention, testing and treatment services for pregnant women and children within health care facilities; and working to overcome some of the cultural issues and stigma associated with HIV.

  The need for programs to fight pediatric HIV/AIDS has never been greater, with more than one child becoming infected with HIV every minute of every day. According to the World Health Organization (WHO), 2.3 million children under the age of 15 are living with HIV/AIDS worldwide. Without care and treatment, it is estimated that three out of every ten children with HIV will die before they reach their first birthday, 50 percent by 2 years and 60 percent before they reach 3 years old.

  "Abbott Fund began providing support for the care and treatment of HIV-infected children in resource-poor settings even before it was widely accepted by many experts," said Mark Kline, M.D., president of the Baylor College of Medicine International Pediatric AIDS Initiative at Texas Children's Hospital. "Thanks to their continuous support, we find ourselves at the dawn of a new era of hope for hundreds of thousands of children across Africa and around the world."

New Programs Make Pediatric HIV Care More Accessible

  Abbott Fund is providing new grants to Catholic Medical Mission Board (CMMB), the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) and Family Health International (FHI) to explore new approaches to identify and enable women and children to better access HIV testing and treatment services in Malawi, Kenya and Tanzania. In 2007, these initiatives are anticipated to help nearly 40,000 pregnant women receive HIV testing and more than 5,000 children receive HIV treatment through the following outreach efforts:

    -- Abbott Fund will work with EGPAF in Tanzania to better identify and
        provide care and treatment for children and families affected by HIV;
        this program also will focus on working to stop the spread of HIV from
        pregnant mothers to their unborn children (known as prevention of
        mother-to-child transmission, or PMTCT).

    -- Abbott Fund's support will enable CMMB, through its work at
       71 faith-affiliated health centers throughout Kenya, to provide HIV
       counseling, testing, treatment and PMTCT services to pregnant women in
       rural Kenyan villages, as well as provide infant care.

    -- Abbott Fund is partnering with FHI in Malawi and Tanzania to reach
       thousands of children with comprehensive HIV prevention, care and
       treatment services.  FHI is integrating these services into its
       existing, large-scale HIV prevention and treatment programs in both countries.

  With these new grants, Abbott and Abbott Fund have now invested more than $70 million over the past seven years on pediatric HIV prevention, testing and treatment programs.

AstraZeneca Launches New Asthma Inhaler;
Challenges GlaxoSmithKline’s Dominance

  Symbicort, AstraZeneca’s new asthma inhaler is set to challenge Advair, GlaxoSmithKline’s top-selling drug, even though they are similar. Both are used for long-term maintenance treatment of asthma as the 21 million Americans suffering from the disease is climbing.

  Both Advair and Symbicort contain a corticosteroid and long-acting beta antagonist. Also, they both carry black-box label warnings stating that long-acting beta antagonists may increase the risk of asthma-related death.

  One major difference between these medications: Advair is approved to treat a wide range of patients, including children, adults and COPD in adults.  Symbicort is approved only for use in adult asthmatics.

  AstraZeneca plans to apply for U.S. FDA approval in 2008 to market Symbicort for pediatric asthma and COPD.

Barr Confirms Aggrenox Patent Challenge;
Boehringer Ingelheim Responds with Suit

  Barr Pharmaceuticals, Inc. confirmed its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Boehringer Ingelheim in connection with its Aggrenox (Aspirin/Extended- Release Dipyridamole) 25 mg/200 mg capsules. The company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Aggrenox.

  Barr filed its ANDA containing a paragraph IV certification for a generic Aggrenox product with the FDA in January 2007, and received notification of the application's acceptance for filing in May 2007. Following receipt of the FDA notice, Barr notified the New Drug Application (NDA) holder and patent owner.

  In July  2007, Boehringer Ingelheim, et al., filed suit in the U.S. District Court of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.

  Aggrenox (aspirin/extended-release dipyridamole) capsules is prescribed to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis. The product had sales of approximately $258 million in the U.S. in 2007.

Diabetes Drug’s Long Trial
Shows Good Results

  The Amylin Pharmaceuticals, Inc. and Eli Lilly & Co. study showed many patients treated with Byetta were able to maintain good blood-sugar control and lose weight after three years of the drug.

  An injection taken before morning and evening meals, Byetta received FDA approval in 2005 for use with patients with Type 2 diabetes who were unable to experience effective lowering of their blood-sugar or blood glucose levels with other diabetes medications.

  Byetta is a synthetic form of hormone taken from a lizard. It is similar to a human hormone in the digestive track known as GLP-1. This hormone boosts insulin production to regulate blood-sugar levels.

  With Byetta added to their other drugs, diabetes patients. After three years, 46 percent were able to maintain blood-glucose levels of 7% and 30 percent had levels of 6.5

  Patients also lost an average of 11 pounds over the three-year period.

U.S. House Panel Backs
Stronger Post-Market System
For FDA Drug-Safety Regulation

  This new clout would enable the FDA to better regulate drugs after they go to market. Overhaul of drug-safety laws experienced strong bi-partisan support in the House Energy and Commerce health subcommittee. The full House vote is likely in July 2007.

  One bill gives the FDA authority to decide which drugs should enter into post-market risk-management programs. These would include three years of annual safety reviews.

  Provisions also allow the FDA to fine drug companies for “false or misleading” advertisements

  User-fee agreements which expire in September 2007 must be negotiated to fund part of the FDA’s budget. The renewed user-fees will last until 2012.  In the past, these have been focused primarily on pre-market drug review. Now, provisions will aim at funds also being used to toughen drug-safety overview.

  The FDA has proposed collecting $393 million from drug companies in 2008.

FDA Gives Nod
To Computerized Pillbox
Available in 2008

  Approval for the Electronic Medication Management Assistant (EMMA) is for patient home use under supervision of a health-care provider

  EMMA can be programmed to dispense individual doses of up to one month’s worth of 10 different drugs. Being Web-connected allows the box’s dosing schedules loaded into it to be tweaked by pharmacists, doctors and nurses.

  It is hoped the breadbox-sized device will reduce drug identification and dosing errors, according to the FDA. Expected users include aging and forgetful patients, plus those with HIV with complex treatment regimens.

LAB International Announces
Name Change to Akela Pharma Inc.

  LAB International Inc., a drug development company focused on developing therapies for the inhalation and pain markets, announced it has formally changed its corporate name to Akela Pharma Inc. The Corporation's website and email domain name has been changed to www.akelapharma.com. .

  "As part of the LAB Research spin-off and IPO conducted last year, it was contractually agreed they would keep the LAB name. Our new corporate name, Akela Pharma, marks an exciting new chapter in the history of our fast progressing company. It also better reflects our intent to strictly focus on developing therapies for the vast inhalation, pain and CNS markets." said Dr. Halvor Jaeger, Chief Executive Officer of Akela Pharma Inc.

About Akela Pharma Inc.

  Akela Pharma is an integrated drug development company focused on developing therapies for the growing multi-billion dollar inhalation and pain markets. Its lead product, for the treatment of breakthrough cancer pain, is a fast-acting Fentanyl formulation delivered using the Company's TAIFUNdry powder inhaler platform. Its pipeline also includes therapeutics for asthma, COPD, and growth hormone deficiencies.

Pros, Cons of Alli:
New Fat-Blocking Drug

GlaxoSmithKline’s’ Alli is the first over-the-counter
diet drug to win FDA approval

  Alli prevents the body from breaking down and absorbing about 25% of the fat eaten.

  For those who consume about 2,000 calories a day and eat about 30% fat, the fat-blocking benefit of Alli translates into about 150 calories a day.

  The diet drug’s side effects which can be embarrassing include: flatulence with oily discharge and frequent or loss stools. Users are advised to wear dark pants and bring a change of clothes to work.

  A Glaxo consultant said: “It’s (Alli) not for the average person who wants to take it and doesn’t want to change their diet. It’s for someone who is committed to making a change in diets and lifestyle.”

Novartis Clears EU Hurdle
For Generic Biotech Drug
U.S. industry closely follows European developments

  European regulators this week moved one step closer to approving Novartis AG's version of the blockbuster drug Eprex, known in the United States as Epogen. This action underscored how much further the E.U. is than the U.S. in establishing a formal system for the approval of generic biotech drugs.

  Because of their complexity, regulators have been hesitant to approve generic versions of biologics, even though many are facing patent expirations. In the case of the E.U. and U.S., the current systems for approving generics were designed for chemically-based drugs, allowing for generic versions to be approved with only limited testing in order to keep down costs.

  European regulators, on the other hand, are considered to be further along in the process of developing a framework for approving generic biologics. As a result, American industry experts have increasingly been looking towards Europe for ideas on how to build a similar framework for the FDA.

  This announcement is the latest victory for Novartis and its Sandoz unit -- one of the world's largest manufacturers of generic drug -- in the company's on-going battle to put out generic versions of biologic therapies. These drugs that are made out of living proteins rather than chemicals. In 2006, the company also was granted approval to market a generic version of the biologic Omnitrope.

  Novartis announced that a panel of the E.U.'s Committee of Medicinal Products for Human Use has recommended that the generic version of epoetin alfa made by the company's Sandoz division be approved for use in the European Union. A final decision on the generic, to be made the European Commission, is expected to make a final decision in 60 to 70 days.

  Epoetin alfa is marketed in Europe by Johnson & Johnson under the brand name Eprex, which lost its patent protection in Europe in 2006. Its U.S. patents, however, are good until around 2013, unless they are challenged in court successfully. J&J markets the product in the U.S. under the name Procrit, while Amgen Inc. markets it under the name Epogen.

FDA Places Breast Cancer Drug
On Priority Review Fast Track

  Bristol-Myers Squibb’s breast cancer drug candidate ixabepilone has been granted “priority review” status by the Food and Drug Administration, meaning the agency will decide whether to approve it by late October 2007.

FDA Approves Ranbaxy
for Manufacture, Sale of Generic Norvasc

  Ranbaxy Laboratories announced that the company has received final approval from the U.S. Food and Drug Administration (FDA) to manufacture and market affordable generic alternatives for amlodipine besylate tablets, 2.5 mg, 5 mg and 10 mg.

  The FDA has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Norvasc tablets of Pfizer Pharmaceuticals Inc.

  Total annual market sales for Norvasc were $2.79 billion.

  Amlodipine besylate tablets are indicated for the treatment of hypertension and may be used alone or in combination with other antihypertensive agents. Amlodipine besylate is also indicated for the symptomatic treatment of chronic stable angina and may be used alone or in combination with other antianginal agents.

Diabetes Drug’s Long Trial
Shows Good Results

  The Amylin Pharmaceuticals, Inc. and Eli Lilly & Co. study showed many patients treated with Byetta were able to maintain good blood-sugar control and lose weight after three years of the drug.

  An injection taken before morning and evening meals, Byetta received FDA approval in 2005 for use with patients with Type 2 diabetes who were unable to experience effective lowering of their blood-sugar or blood glucose levels with other diabetes medications.

  Byetta is a synthetic form of hormone taken from a lizard. It is similar to a human hormone in the digestive track known as GLP-1. This hormone boosts insulin production to regulate blood-sugar levels.

  With Byetta added to their other drugs, diabetes patients. After three years, 46 percent were able to maintain blood-glucose levels of 7% and 30 percent had levels of 6.5

  Patients also lost an average of 11 pounds over the three-year period.

Court Upholds Patent, Blocks Sale
Of  Blood Thinner Generic Version
Of Bristol-Myers, Sanofi's Plavix

  A federal court has ruled that a key patent held by Sanofi-Aventis on the blockbuster drug Plavix is valid -- a move that should hold off generic competition for the popular blood-clot medication until 2011. Plavix is jointly marketed by Bristol-Myers Squibb Co. and the French drugmaker Sanofi-Aventis.

  Before Apotex's generic launch in the summer of 2006, Plavix had pulled 2005 sales of $5.9 billion.  Plavix, used to prevent blood clots, ranked second in 2005 among the best-selling drugs in the world, after Pfizer Inc.'s cholesterol drug Lipitor.

  A New York district court ruled that Canadian generic drugmaker Apotex Inc. failed to prove that the Plavix patent in question was invalid or unenforceable, according to court documents. Apotex has been seeking to have the Plavix patent thrown out in order to be allowed to market a less costly generic version.

  The ruling also prevents Apotex from marketing a generic version of Plavix in the U.S. until the patent expires in November 2011.

FDA Sets Digital Procedure
For Drug-Label Submissions

Digital versions of drug labels will be used
to build a public online archive

  The FDA is expected to announce a format that will completely change the layout and content of the labels. This is part of a plan to create a centralized source with up-to-date labels.

  This digital requirement will force drug makers to submit all new or changed labels in a format that can be searched or used to build a database.

  As they are submitted, the labels will be placed in a public online archive called Daily Med at http://dailymed.nlm.nih.gov

AMA to Ask for Federal Scrutiny
Of In-Store Health Clinics
Near Pharmacies

Walgreen, Wal-Mart and CVS/Caremark plans
to bring several thousand retail health clinics
to U.S. consumers targeted

  On the one side, the AMA action indicates that the organization and its affiliated state societies will push for increased regulation and try to slow down the proliferation of these clinics. An AMA spokesman said that its main focus is patient safety and care which is jeopardized by the retail clinics’ mission to sell products and prescriptions.

  On the retail side, health clinic operators perceive the AMA move as a physicians’ protectionist measure. They also see this move as contrary to the people’s demand for accessible and affordable health care.

  Health insurers have further aggravated the situation by creating what the AMA calls “an unfair playing field” by waiving patients’ co-payments at retail health clinics.

  Retail clinics say they and the nurse practitioners who staff them know their limitations and have increasingly been establishing referral relationships with hospitals. MinuteClinic operators claim their studies show “99 percent satisfied” patients.

  Although the health clinics do not treat patients less than 18 months, one AMA leader of pediatric care thinks this field is too complex for nurse practitioners and the retail clinics should increase the age limit to three years or even older.

Biogen Idec, FDA Warn
About Cancer Drug Problem

Cancer drug, Zevalin, used to treat non-Hodgkin’s lymphoma
which has been non-responsive to other treatments
is causing severe skin reaction, “some with fatal outcome”

  Zevalin’s black box label already warns of the possibility of fatal reactions within 24 hours of the drug being administered to patients. The label has been updated to discuss the skin reactions.

Applied Biosystems Develops Test Kits
To Detect Avian-Flu Virus

Test to help researchers to better track
genetic changes in the virus requires
more testing before it can become
widely available

Drug Makers Face Challenge:
As Golden Era for Heart Therapies Wanes
What Will Take up the Slack in Sales?

Cardiovascular medicines are so effective,
developing new, better drugs is a struggle

  Blockbuster sales of treatments like Lipitor (Pfizer), Norvasc (Pfizer), Zocor (Merck) and Diovan (Novartis) fueled a golden era for these pharmaceutical companies. The drug industry has made remarkable headway in combating the world’s top killer — heart disease. As a result, the medications developed became bedrock business for these makers.

  Now, many pills have lost their patent protection and gone generic and the patent lives of others are nearing expiration. Those developing drugs for diabetes which sharply increases cardiovascular risk are finding the effectiveness of current treatments is a major hurdle for their new product.

  Takeda Pharmaceutical’s Actos diabetes drug is in a big study to prove the benefit against heart attacks in patients with Type 2 Diabetes. With patients coming into the tests very well taken care of with current medications, Takeda will have to “convincingly say what it is that we bring to the table that isn’t already there,” according top Takeda spokesman.

  More new drugs will face this greater difficulty of trying to show incremental benefit against a standard of care instead of against a placebo. In order to have enough statistical power to prove the smaller improvement, companies will need larger and more expensive studies.

  Many doctors feel that we should use the very effective current drugs for cardiovascular care combined with healthier living through diet, exercise and quitting smoking.

FDA Panel Leaves 3 Asthma Drugs on U.S. Market;
Now All Will Carry Black Box Warnings

Concerns about causing rare sometimes fatal  
severe asthma attacks linked to Serevent,
Advair and Foradil

All three drugs are approved for long-term, scheduled-maintenances treatment of asthma and chronic obstructive pulmonary disease. A panel member and infectious diseases and allergy expert with the Natonal Institutes of Health states," These drugs are standard of care for all but the mildest of asthmatics."

Serevent and Advair are produced by GlaxoSmithKline; Foradil is produced by Schering-Plough.

Some 20 million Americans have asthma.