ANDRX SCORE CARD 2/27/00
Safe Harbor... blah blah
1. Absolutely no guarantee as to accuracy of the following data taken from publically available info.
2. Feel free to correct or contribute as needed.
**** APPROVED PRODUCTS
Cartia XTTM (Diltiazem HCl Extended-Release Capsules, USP) Once-a-Day Dosage
Hypertension and angina
Approved: July, 1998
Marketing: June 23, 1999
Brand Sales (Cardizem© CD): > $750 million (1997).
Etsimated sales 6 months exclusivity: $115 million.
Diltia XTTM (Diltiazem HCl Extended-Release Capsules, USP) Once-a-Day Dosage
Hypertension and stable chronic angina
Marketed: October 10, 1997
Brand: Watson Pharmaceuticals.
Brand Sales (Dilacor XR©): $130 million (1997).
Comment: 12/99 best quarter ever.
Pentoxifylline Extended-release Tablets, 400mg
Vasodilator
Launch: September 4, 1998
Andrx and Watson Pharmaceuticals (ANCIRC)
Brand Co: Hoechst Marion Roussel
Brand Sales (Trental©): $153 million (1997).
Comment: developed by Andrx and will be manufactured by Watson and marketed by Andrx.
Ketoprofen ER
Arthritis
Approval and Launch: April, 1999. Suspended July, 1999
ANCIRC joint venture
Brand Sales (Oruvail©):
Brand Co: Wyeth-Ayerst (AHP)
**** PRODUCTS PENDING APPROVAL
Prilosec© (omeprazole)
Gastric ulcers, duodenal ulcers, erosive esophagitis and gastroesophogeal reflux disease.
Aura Labs.
ANDA: early 1998. First to file.
Brand Co: AstraZeneca
Brand Sales: $2.933 billion (****1998 USA sales). $4+ billion (Worldwide).
Potential Launch: October 2001
Patent expires: April 1, 2001
Comments:
Analyst Dave Peltier (2/15/00) Stock Of The Day:
"Despite the fact that it won't hit the market for another 18 months, estimates abound that
Andrx's generic <Prilosec> could bring in sales of almost $200 million in its first three months."
Merk's 10K-405 3/99: "In addition, Prilosec will face expiration of a product patent in 2001. In the aggregate, domestic sales of these products represent 22% of the Company's human health sales for 1998. The Company expects a significant decline in these sales in the years 2000 through 2002 upon the loss of market exclusivity. With the exception of Prilosec, for which the Company has U.S. rights only, a decline is also expected in the Company's European sales for these products in the years 2000 through 2005 upon the loss of market exclusivity in European countries throughout this period.
Tiazac© a once-a-day diltiazem HCl ER capsule.
Anti-hypertensive/cardiac/blood pressure control/
ANDA filed: September 1998.
Brand Marketer: Biovail Corporation/Forest Marketer
Brand Sales: estimated $100-200 million ?.
Potential Launch: June/July 2001 if ANDA approved.
Comment: Litigation by Biovail.
Naprelan© a once-a-day naproxen sodium ER tablet
NSAIDs, Arthritis
ANDA filed: September, 1998. ( First to file ???).
Brand Marketer: Elan.
Brand Sales (Naprosyn/Naprelan): Naprelan = $100-$200 million ?
Potential Launch:
Comment: Litigation by Elan.
Wellbutrin SR(R), is a buproprion hydrochloride extended-release tablet
Depression
ANDA filed: August 31, 1999. Paragraph IV. First to file (150 mg) ?
Brand CO: Glaxo Wellcome, Inc.
Brand Sales (Wellbutrin): $492 million (1998)
Potential Launch: ????
Comment: Litigation by Glaxo.
Zyban(R) buproprion hydrochloride extended-release tablet
Cessation of smoking
ANDA filed: August 31, 1999. Paragraph IV. First to file.
Brand CO: Glaxo Wellcome, Inc.
Brand Sales: $200-$300 million (estimated 1998)
Potential Launch: ????
Comment: Litigation by Glaxo.
K-Dur(R), potassium chloride extended-release tablet
Potassium supplement
ANDA filed: August 31, 1999. Paragraph IV.
Brand Marketer: Key Pharmaceuticals, Inc. (Schering Plough Corporation).
Brand Sales: > $50-$100 million ? (estimated 1998)
Potential Launch: ????
Claritin D-24© once-a-day antihistamine
Allergies
ANDA filed: Feb. 15, 2000. Paragraph IV. First to file.
Brand Co: Schering Plough
Brand Sales: > $350 million
Potential Launch: 2003
**** DEVELOPMENT
Metformin XT (Glucophage) a once-a-day formulation of metformin hydrochloride
Diabetes
Phase III start: 2Q 2000.
Brand Co: Bristol-Myers Squibb Co.
NDA expected: 2Q 2001.
Marketing rights licensed for the U.S. and certain international territories. Royalties on
manufacture.
Brand Sales: $500 million.
Lovastatin XL
Hypercholesterolemia
Phase III: Current.
Aura Labs.
Brand Co: Merck.
NDA expected: 1Q 2001.
Patent Expires: June 15, 2001.
Brand Sales: $595 million.
Undisclosed
Central Nervous
Brand Sales: $175M
Clincal Trials: I
Undisclosed
Central Nervous
Brand Sales: $1.5 billion
Undisclosed
Analgesic
Brand Sales: $300M
Clincal Trials: I
Andrx Pharmaceuticals' pipeline includes approximately 20 bioequivalent products (ANDAs) in various stages of development.
**** PARTNERS AND LICENSING
BAYER CORPORATION
Andrx has an agreement with a Bayer (BAYZ) affiliate to develop a controlled-release, over-the-counter product. The first product from the agreement has already been filed with
the FDA.
March 25, 1999 - another agreement with an affiliate of Bayer Corporation to develop a new product. This is the second collaboration between the parties applying Andrx' drug delivery technologies to the Bayer affiliate's over-the-counter (OTC) product creating a controlled-release version of that product.
GENEVA
In June 1999, the Company entered into an agreement with Geneva Pharmaceuticals, Inc., a member of the Novartis Group ("Geneva"), for the sale and marketing of
certain products. The agreement includes funding by Geneva of certain controlled-release dosage forms of existing products that Andrx is developing for submission as New Drug Applications ("NDA"), the grant of marketing rights
to Geneva in certain territories for these products, and the receipt by Andrx of at least certain minimum amounts of royalties from the sale of such products. These products will help build Geneva's branded generics portfolio both in the US and in Europe. The Company has also committed to continuing to sell generic products marketed by Geneva. Many of Geneva's products are in these therapeutic categories: psychotherapeutics, cardiovascular and nonsteroidal anti-inflammatory medications.
SEPRACOR - ** DEAL IS OFF *** ???
In April 1996, the Company entered into a collaboration agreement for the development of a brand name controlled-release pharmaceutical product with Sepracor, Inc. ("Sepracor"). Pursuant to this agreement, Andrx is using one of its controlled-release drug delivery technologies to formulate a once-a-day version of fexofenadine (previously known as terfenadine carboxylate), an antihistamine being developed by Sepracor. A twice-a-day version of this drug was approved by the FDA in 1996, and is marketed in the U.S. under the brandname Allegra/registered trademark/ by Hoechst Marion Roussel, Inc. Under thedevelopment agreement with Sepracor, the Company is responsible for developing a formulation of the product and transferring such technology to Sepracor who will be responsible for obtaining FDA approval for the product and the commercialization of the product. The Company has received certain fees under the development agreement and will be entitled to receive royalties from the sale or license of the product.
Andrx currently has seven ANDAs awaiting FDA approval for controlled-release products which
address annual U.S. brand sales of approximately $5 billion.
Analyst Dave Peltier (2/15/00) Stock Of The Day: The gross product margin that the company
enjoys on its own drugs of more than 80% is about four times greater than what is sells from
third-party suppliers.
Andrx has a strong pipeline ? including two drugs nearing the end of trials and three others that should hit the market in the next twelve months. The company expects to still hold 35% to 40% of the generic market in this drug for 2000, which could equal up to $100 million in additional sales.
9 MONTHS ENDING SEPT 1999
Gross profits from sales of distributed products was $37.6 million, with a gross margin of 19.3% in the 1999 Period, as compared to $23.5 million, with a gross margin of 15.1% in the 1998 Period.
Gross profits from sales of manufactured products were $68.3 million, with a gross margin of 82.3% in the 1999 Period, as compared to $4.2 million, with a gross margin of 52.5% in the 1998 Period.
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