---

---

Patent News

---

Vytorin
The Food and Drug Administration has approved a new cholesterol-lowering drug called Vytorin. The pill, manufactured and marketed by a joint venture between Merck & Co. Inc. and Schering-Plough Corp., is a combination of two other cholesterol drugs, Zetia and Zocor.  Zocor is from the class of drugs known as statins, and lowers cholesterol by cutting its production in the liver. Zetia limits the absorption of cholesterol in the intestines.

---

Campral
The American government approved the first new drug to treat alcohol abuse in a decade a medicine called Campral that promises to help ward off relapses.  Campral is known chemically as acamprosate. It is not for patients who are actively drinking at the start of treatment or who abuse other substances in addition to alcohol.  It is thought to somehow ease alcoholism withdrawal symptoms by normalizing abnormalities in two brain chemical systems. Most common side effects were headache, diarrhea, flatulence and nausea, FDA said. Campral is made by France's Lipha Pharmaceuticals. It has been widely used in Europe for years. In the United States, there are two other FDA-approved drugs for alcohol abuse treatment: antabuse and naltrexone.  Antabuse reacts with alcohol to make the drinker violently ill, and naltrexone blocks brains chemicals that make alcoholics feel good after a drink.

---

Alclometasone Dipropionate Ointment
Taro Pharmaceutical Industries Ltd. reported today that its U.S. affiliate has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Alclometasone Dipropionate Ointment, USP 0.05% ("alclometasone ointment").  Taro's alclometasone ointment is bioequivalent to GlaxoSmithKline's Aclovate(R) ointment, a low to medium potency topical corticosteroid product. Alclometasone ointment, a prescription product, is used for the treatment of inflammatory skin diseases. U.S. sales of Aclovate(R) ointment were approximately $2.5 million in 2003.

---

Fluconazole
Diflucan(R) (Fluconazole) is indicated for the treatment of vaginal candidiasis (vaginal yeast infections due to Candida), oropharyngeal and esophageal candidiasis, and cryptococcal meningitis. Fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.  Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced that RLL has received approval from the U.S. Food and Drug Administration to manufacture and market Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mg strengths and Fluconazole for Oral Suspension, 10 mg/mL (50 mg/5mL) and 40 mg/mL (200 mg/5mL). The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Diflucan(R) of Pfizer Central Research. Total market sales for Fluconazole were $741 million (IMS - MAT: March 2004). Tablet sales represented a total of $469 million and the suspension $28 million. 

IVAX Corporation, Mylan Laboratories Inc., Par Pharmaceutical Companies, Inc. and Teva Pharmaceutical Industries Ltd. also announced that the U.S. Food and Drug Administration has granted final approval for the ANDA for Fluconazole.

---

Synagis
In 1998, the original formulation of Synagis (palivizumab) was approved by the FDA to prevent serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease. Synagis is the first monoclonal antibody approved for prevention of an infectious disease, and the first such drug to be safely used in children. MedImmune, Inc. announced in July that the U.S. Food and Drug Administration (FDA) has approved a new liquid formulation of Synagis.

---

NT-proBNP
Dade Behring Holdings, Inc. announced it had received FDA clearance to sell its NT-proBNP (N-terminal pro brain natriuretic peptide) assay in the United States. NT-proBNP is a key cardiac marker, which will be used on the company's Dimension® instruments as an aid in the diagnosis of individuals suspected of having congestive heart failure.

---

Magnetocardiograph (MCG)
CardioMag has received clearance from the Food and Drug Administration (FDA) to market and sell in the United States its revolutionary cardiac device, called a magnetocardiograph (MCG), which can detect the magnetic field generated by a person's heart. The CardioMag system has demonstrated that it is capable of working in a typical open clinical setting, such as the non-invasive cardiology lab at Cedars-Sinai Medical Center where groundbreaking research is being carried out. An MCG procedure takes less than ten minutes to perform, is risk-free, and does not require injections or radiation. Generating a thousand images per heartbeat CardioMag's MCG system provides unprecedented insight into the human heart at work.

---

Gemzar
Ovarian cancer causes more deaths in Europe than any other cancer of the female reproductive tract, with approximately 20,000 new cases of ovarian cancer diagnosed annually.  Ovarian cancer is particularly lethal because of the disease's vague symptoms and high recurrence rate. Ninety percent of women with advanced ovarian cancer will experience a recurrence of the disease after initial treatment. Lilly announced that regulatory officials in several European markets including but not limited to Germany, Sweden, Denmark, Finland, Belgium, Hungary, Portugal, and Romania, have approved Gemzar in combination with carboplatin, a standard chemotherapy agent, for the treatment of recurrent epithelial ovarian cancer.

---

Alinia
The U.S. Food and Drug Administration (FDA) had approved Romark Laboratories' Alinia(R) (nitazoxanide) tablets for treating diarrhea caused by Giardia lamblia in patients 12 years of age and older.

---

Piperacillin
Piperacillin is a third-generation, antibiotic indicated for the treatment of serious infections caused by designated susceptible microorganisms such as P. aeruginosa commonly referred to as pseudomonas.  Piperacillin is active against a variety of gram-positive and gram-negative aerobic and anaerobic bacteria. American Pharmaceutical Partners, Inc., received approval from the U.S. Food and Drug Administration (FDA) to launch a 40g vial of Piperacillin for Injection, USP, the generic equivalent of Wyeth's Pipracil(R).

---

Levofloxacin
The U.S. Food and Drug Administration (FDA) has approved the fluoroquinolone antibiotic LEVAQUIN(R) (levofloxacin) tablets/Injection and LEVAQUIN(R) (levofloxacin in 5% dextrose) Injection to treat multi-drug resistant strains of Streptococcus pneumoniae in community acquired pneumonia (CAP).  Approximately four million people in the United States develop CAP each year. S. pneumoniae is one of the primary bacteria that causes CAP.  Multi- drug resistant S. pneumoniae (MDRSP) are forms of bacteria resistant to two or more therapeutic classes of antibiotics including penicillin, second- generation cephalosporins, macrolides, tetracyclines and sulfonamides. The presence of multi-drug resistant S. pneumoniae has increased significantly over time and today represent up to 23 percent of all strains.

---

Imiquimod
The U.S. Food and Drug Administration (FDA) has approved the first prescription therapy in nearly a decade for the treatment of superficial basal cell carcinoma (sBCC), a type of nonmelanoma skin cancer. 3M's Aldara(TM) (imiquimod) Cream, 5%, a topical immune response modifier, is now available to treat biopsy-confirmed, primary sBCC in adults with normal immune systems.

---

ImageChecker
The U.S. Food and Drug Administration (FDA) for the ImageChecker(R)CT CAD Software system. R2 Technology's ImageChecker CT system is the first CAD system to receive an approval for computer-aided detection of solid lung nodules during review of multi-detector CT (MDCT) chest exams. Early lung cancer often presents as nodules and can be difficult to detect in its early stages.

---

Erbitux
German drug maker Merck KGaA said it had received European Union approval to sell the colon cancer drug Erbitux, co-developed with U.S. biotech company ImClone Systems Inc. and Bristol-Myers Squibb. The drug will be available in all 25 EU member states as well as Iceland and Norway in accordance with local laws. The German company, which has no connection with the U.S. drug company Merck & Co., holds the rights to Erbitux outside North America.
Erbitux is a monoclonal antibody that works by blocking a protein that can promote aggressive forms of the disease.  ImClone received approval from the U.S. Food and Drug Administration earlier this year. Bristol-Myers Squibb has the marketing rights to Erbitux in North America.

---

Leeches
Medicinal leeches normally make their home in fresh water.  The use of leeches (Hirudo medicinalis) to draw blood goes back thousands of years. They were widely used as an alternative treatment to bloodletting and amputation for several thousand years. Leeches reached their height of medicinal use in the mid-1800s.  The Food and Drug Administration said in June that Ricarimpex SAS, a French firm, was the first company to request and receive FDA clearance to market the bloodsucking aquatic animals as medical devices. FDA noted that today they are used in medicine throughout the world as tools in skin grafts and reattachment surgery. Leeches are already widely used in American hospitals, and companies that raised and sold them here before 1976 were allowed to continue doing so.

---

Prednisone
Prednisone is a corticosteroid used to relieve inflammation including swelling, heat, redness, and pain; to treat certain forms of arthritis; skin, blood, kidney, eye, thyroid, and intestinal disorders such as colitis; severe allergies; and asthma. Prednisone is also used with other drugs to prevent the rejection of transplanted organs and to treat certain types of cancer.  Prednisone is one of the top 10 retail products according to patient counts. During the year 2003, Prednisone had 22 million prescription counts filled by 11.64 million patients (NDC Market Focus). The market is estimated to be at $46 million. GeoPharma, Inc. announced that they had acquired the rights to market the ANDA drug Prednisone as branded through their wholly owned subsidiary, Belcher Pharmaceuticals, Inc. GeoPharma will offer dosage strengths of 5 mg, 10 mg, 20 mg and 50 mg tablets and begin distributing their Belcher Pharmaceuticals' branded product by fall of 2004.

---

Medroxyprogesterone
Medroxyprogesterone Acetate Injectable Suspension is the generic equivalent of Pfizer's Depo-Provera(R), an injectable contraceptive. Annual brand sales of single dose vials are approximately $170 million. Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Medroxyprogesterone. This is the first generic approval for this product.

---

Dream Workshop
Tokyo-based Takara Co. says its "Dream Workshop" stand, shaped like an oversized cellular phone dock and about 35 centimeters (14 inches) tall -- can be programmed to help sleepers choose what to dream. While preparing for bed, the user mounts a photograph on the device of who should appear in the dream, selects music appropriate to the mood -- fantasy, comedy, romantic story, nostalgia -- and records key word prompts, such as the name of a romantic crush. Placed near the bedside, the dream-maker emits a special white light, relaxing music and a fragrance to help the person nod off. Several hours later, it plays back the recorded word prompts, timed to coincide with the part of the sleep cycle when dreams most often occur. It then helps coax the sleeper gently out of sleep with more light and music so that the dreams are not forgotten.
The device will sell for 14,800 yen (U.S. $136) in Japan starting late August. In a study conducted on a group of men and women between the ages of 20-40, the device had a success rate of 22 percent in inducing dreams in which one of the prompt words appeared, said the Yomiuri Shimbun, a major daily.

---