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Strategies & Market Trends : Rande Is . . . HOME -- Ignore unavailable to you. Want to Upgrade?

To: Rande Is who wrote (4422)	3/19/1999 8:57:00 AM
From: makin_dough99	Read Replies (3) \| Respond to of 57584

EXTRA! EXTRA! (Today's Feature Headlines) ***************************************** STRENGTH OF OIL AGREEMENT BODES WELL FOR SMALL CAP ISSUERS By John Dawe For many small cap oil related issuers it has seemed like an eternity since there was any hope of improved crude prices. Over the past year in particular the outlook has seemed to get increasingly bleak as major firms such as Exxon and Mobil announced mergers based on forecasts that profitability could only be maintained through cost reduction programs. When the giants can't make a go of it, it's hard to be optimistic when you're at the helm of a front line junior. However, all that now seems to be changing as The Organization of Petroleum Exporting Countries (OPEC) and other major oil producing countries appear to be in harmony over a plan for a reduction in production levels which is set to be ratified at OPEC's meeting in Vienna on March 23rd. As we reported last week in The Small Cap Express, the basis for this agreement is an initiative by Saudi Arabia, Kuwait, Oman and Qatar who stated they would “take all necessary measures” to win the cooperation of OPEC members and other producing nations. In our last update we noted that the possible success of this arrangement was suspect because Venezuela, OPEC's third largest producer, had not yet signed on. This has now changed and on Friday the oil minister of Venezuela joined with his peers from Saudi Arabia, Iran, and Mexico to announce they had reached agreement on plans to reduce world production by 2 million barrels a day. The composition of this group also represented encouraging news because it had been questionable whether the other producing states could reach agreement with Iran regarding the base level of production from which it would make cuts. Saudi Arabia and Kuwait will play a leading role under this plan and have each agreed to reduce their output by 7.3%. Outside of OPEC, compliance by Russia is seen as a major factor in the possible success of the plan. Although it has not expressed a firm commitment, Russia appears to be leaning toward signing on and the performance of futures contracts over the past couple of days indicates markets are supporting this outcome. Overall, the agreement involves about a dozen oil producing countries and represents a reduction of approximately 2.7% of the world supply of oil. Markets have reacted well to these developments over the past week and crude futures have traded around their hit six-month highs. Yesterday, Brent Crude May delivery futures traded up $0.59 to close at $13.27 per barrel and West Texas Intermediate Crude April delivery futures saw an increase of $0.59 to close at $15.05 per barrel. In terms of outlook, some analysts are predicting that a 70% compliance rate among signatories to the deal could push crude price up by roughly $1.00 to $2.00 over the next three months. However, currently there is a substantial global inventory of 500 million barrels of crude still overhanging the market and this deal will have to hang together for a year or more in order for the glut to be absorbed. From the perspective of the small cap issuer and investor, these signals are mixed for the short run, but are generally encouraging over the longer haul. As covered in our article on contrarian investing, if you have a risk oriented long-term investment outlook, this may be a classic time to consider re-positioning portfolio to include some exposure to the small cap oil sector. This sector has been bid down dramatically over the last couple of years and has effected the prices of companies from Alberta down to the gulf coasts of Louisiana and Texas. At present the large cap stocks of the Dow and Nasdaq are dominating headlines and capturing the imagination of investors. However for those with an orientation toward value investing, there are a wealth of opportunities available in undervalued Canadian and American small cap oil issues. Let's face it, there's no doubt that progressively bigger numbers on the Dow are a lot of fun to watch. But, in the long run, seeing your portfolio increase due to a well timed selection of an undervalued play may be a lot more fulfilling. To access reports relating to this story you may wish to try the following hyperlinks: nationalpost.com cbcnews.cbc.ca 312 cnnfn.com cbs.marketwatch.com quote.bloomberg.com

To: Rande Is who wrote (4422)	3/19/1999 9:17:00 AM
From: Rande Is	Respond to of 57584

FDA Grants Tentative Approval to First Generic Challenger to Procardia XL(R) Using Penwest's TIMERx(R) Technology - Marks First Drug Containing Penwest's Technology to Receive Tentative Approval in The United States - PATTERSON, N.Y., March 19 /PRNewswire/ -- Penwest Pharmaceuticals Co. (Nasdaq: PPCO) announced today that the Food and Drug Administration (FDA) gave Mylan Pharmaceuticals, a division of Mylan Laboratories (NYSE: MYL), a tentative approval to an AB-rated generic version of Pfizer's Procardia XL(R) (nifedipine), one of the largest selling drugs for hypertension and angina. The generic drug, approved for a 30 mg dose, is a joint effort of Penwest and Mylan. Penwest and Mylan developed the product using Penwest's proprietary TIMERx controlled release drug delivery technology. Mylan will handle production, distribution and marketing of the new drug. The designation by the FDA as AB-rated, a certification of bioequivalence, will allow pharmacies to substitute this generic version when a physician prescribes Procardia XL. Reacting to the FDA decision, Penwest said today that Mylan's nifedipine formulation which utilizes TIMERx controlled release technology had passed stringent FDA bioequivalence guidelines. Mylan's generic nifedipine controlled release tablet using Penwest's proprietary drug delivery technology has undergone extensive testing to meet FDA guidelines. "We are pleased that the FDA has given its tentative approval to a product containing TIMERx," said Tod Hamachek, Chairman and Chief Executive Officer of Penwest. "This generic form is as safe and effective as Procardia XL and will offer a lower cost alternative to patients." The application has now been cleared from a regulatory perspective, but final approval will not be granted until certain legal issues, including the patent lawsuit brought by Bayer and Pfizer against Mylan, have been resolved. Penwest began working with Mylan in 1994 on a generic version of Procardia XL. In May 1997, Mylan became the first company to file an ANDA (abbreviated new drug application) for a generic nifedipine version of the 30 mg strength of Procardia XL. Mylan's filing was significant for Penwest because it was the first regulatory filing in the United States for a product incorporating TIMERx technology. Since Mylan was the first to file with the FDA and to certify the invalidity and non-infringement of a listed patent, Penwest expects that the 30mg product will have a minimum of 180 days of generic market exclusivity after final approval by the FDA. Hamachek added "This FDA approval marks the third drug utilizing our TIMERx technology to receive international regulatory clearance, following approvals in the last year of nifedipine in the United Kingdom and oxybutynin in Finland, Austria, Ireland and the Netherlands. The TIMERx technology is highly adaptable to a variety of different oral drugs, including both soluble and insoluble. The TIMERx system is currently being utilized in several other drug development initiatives worldwide." Penwest Pharmaceuticals Co. is engaged in the research, development and commercialization of novel drug delivery technologies. Based on its experience in developing and manufacturing tabletting ingredients for the pharmaceutical industry, the Company has developed its proprietary TIMERx controlled release drug delivery technology, which is applicable to a broad range of orally administered drugs. The Company is also an established manufacturer and distributor of excipients, the inactive ingredients used in binding, disintegrating and lubricating tabletted pharmaceutical and nutritional products. TIMERx is an innovative, patented oral drug delivery technology developed by Penwest. Currently, there are 55 TIMERx patents pending worldwide and there are 19 patents issued in the United States, two in Europe and three in Japan. Controlled release systems such as TIMERx offer many distinct advantages over immediate dose compounds including possible reduction of side effects and a more favorable release profile. Additionally, the Company believes that the TIMERx technology is particularly beneficial for the development of controlled release products because of its superior performance characteristics and ability to run on conventional tabletting equipment. The matters discussed herein contain forward-looking statements that involve risks and uncertainties, which may cause Penwest's actual results in future periods to be materially different from any future performance suggested herein. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," expects," and similar expressions are intended to identify forward-looking statements. Such risks and uncertainties include the risk that the patent lawsuit brought by Bayer and Pfizer against Mylan will result in an unfavorable outcome for the Company or will be protracted, regulatory risks relating to the drug, actual and potential competition, the risk of additional patent litigation, the timing and outcome of regulatory approval of products, dependence on collaborators and other risks as set forth under the caption "Risk Factors" in the Company's Registration Statement on Form 10, which is on file with the Securities and Exchange Commission which risk factors are incorporated by reference. SOURCE Penwest Pharmaceuticals Co. CO: Penwest Pharmaceuticals Co.; Mylan Pharmaceuticals; Mylan Laboratories; Food and Drug Administration