CEO of Momenta Discusses FDA Acceptance of ANDA Application for Generic Copaxone(R)
MONDAY, JULY 14, 2008.....
Investors already disheartened about the growing problems of the financial sector and the soaring price of oil are facing more depressing news with the release of second-quarter earnings reports. The coming week will bring the first big wave of results from America's largest companies, including seven Dow Jones industrial average components and 53 members of the Standard & Poor's 500 index. Investors shouldn't expect much: Earnings for all the companies in the S&P 500 index are forecast by the rating agency to be down 10 percent from a year earlier. Thomson Financial, which compiles forecasts from analysts at banks and brokerages, estimates the decline at 13.5 percent. Either way, Wall Street is well past the nearly five years of double-digit growth that ended as the subprime mortgage crisis spilled into the credit markets last summer. The credit crisis is responsible for the earnings plight; financial companies that have written down an aggregate of $300 billion in soured mortage-related assets remain the biggest drag on S&P 500 earnings. Results are expected this coming week from Merrill Lynch & Co., JPMorgan Chase & Co. and Citigroup Inc. But profits and outlooks for the future are expected to be sobering for U.S. companies as a whole."The feeling is that this will be a sloppy earnings season, the tone of the which is going to be very much like the previous three quarters," said Phil Orlando, chief equity market strategist at Federated Investors. "The banks and the housing sector, on through autos and retailers, are the problem children." Financial company earnings are forecast to fall by 69 percent year-over-year, according to Thomson. Meanwhile, consumer discretionary companies -- which includes auto manufacturers and home builders -- are expected to see their profits fall by 19 percent. There are some bright points, with energy companies expected to turn soaring oil prices into a 28 percent jump in profits. Crude oil is up nearly 50 percent this year, and hit a record on Friday over $147 a barrel. With both oil and financial earnings certainly at extremes, analysts like Orlando find it useful to strip out their performance to get a better idea of how the broader market performed. If you remove the financials, Thomson forecasts the companies in the index would post an average earnings growth rate of about 9 percent; and if you remove financials and oil, the rest of the S&P 500 would have a 4 percent profit growth rate.
"There's some growth there, but nothing like we've seen in past years," said John Butters, director of U.S. earnings research for Thomson Financial. "You also have to take into consideration that the forecasts have come down during the quarter." He said that at the start of the quarter, analysts expected the financial sector to tumble 31 percent year-over-year. The barrage of bad news during the quarter forced analysts' to rethink their forecasts, causing both expectations and stock prices to fall. Concerns about financials didn't let up on Friday, when the Dow Jones tumbled nearly 130 points on concerns about the viability of Fannie Mae and Freddie Mac. Fannie Mae lost 22.35 percent of its value, while Freddie Mac lost 3.13 percent.
Investment banks -- many of which carry significant investments in mortgage-backed securities -- also fell. Lehman Brothers Holdings Inc., the weakest of Wall Street's firms, tumbled 16.59 percent by the end of the session. And amid this uncertainty, analysts don't expect companies to be very optimistic about the future. By most accounts, lackluster second-quarter results are already factored into stock prices. That makes it even more important for corporate executives to manage expectations going forward. For instance, the CEOs of both General Electric Co. and aluminum maker Alcoa Inc. -- the first of the Dow's 30 components to report -- issued lukewarm guidance. GE matched forecasts on Friday, while Alcoa surpassed them on Tuesday. "Any guidance that management provides, from a self-serving standpoint, will be downbeat and cautious," Orlando said. "They will try to set the bar as low as possible to engineer an upside surprise in the third quarter."
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CEO of Momenta Discusses FDA Acceptance of
ANDA Application for Generic Copaxone(R)
Momenta Pharmaceuticals, Inc. (MNTA) announced that the FDA has accepted for review the Abbreviated New Drug Application (ANDA) for a generic version of Copaxone(R)(glatiramer acetate injection), submitted by Sandoz Inc., Momenta’s 50/50 development and commercialization partner for this product. Copaxone is indicated for the reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (MS). Teva Pharmaceutical Industries, Ltd. (TEVA) reported U.S. sales of $1.1 billion for Copaxone for the twelve months ended 2007. Craig A. Wheeler, President and CEO of Momenta, commented in a conference call Friday, "Clearly, a generic version of Copaxone represents a significant market opportunity for us." He added, "This ANDA provides additional evidence of our ability to apply our technology to the characterization of complex mixtures." Teva stated today that it intends to file a patent infringement lawsuit against Momenta/Sandoz. Teva believes the suit will stay the ANDA filed by Momenta/Sandoz.
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The President, COO and Chief Scientific Officer of DARA BioSciences, Inc. (DARA), John Didsbury, Ph.D., presented Thursday at the Collins Stewart’s 4th Annual Growth Conference in New York, NY. DARA Bio- Sciences is a development-stage pharmaceutical company that acquires and develops promising drug candidates. DARA focuses its therapeutic development efforts on small molecules from late preclinical development through phase 2 clinical trials. DARA has a portfolio of therapeutic candidates for neuropathic pain, type 2 diabetes, and psoriasis. Dr. Didsbury explained at the conference, "We are executing a unique pharmaceutical product development business model. This model is designed to maximize returns to shareholders, minimize risk, and dramatically reduce the revenue generation time frame in the pharmaceutical industry sector." "We develop drugs that address large markets. We are very product-focused, beginning with identified drug molecule candidates with strong patent production. We are reducing product development risks.We are opportunistic and not therapeutically-focused. We are also focused on the lower-cost, higher-return stages of development. These include late preclinical through to Ph IIa stages," added Dr. Didsbury. "Our corporate strategy is unique. We are not involved in early drug research, which has the highest risk. We also do not participate in Phase III studies, which incur the highest costs. We are very flexible, and we cut programs quickly that have adverse results. We don’t hang on to ‘dogs’." He concluded, "We have a clearly defined business strategy that addresses pharmaceutical pipeline gaps. We are not relying on one candidate or one therepeutic category. We have a diverse portfolio. We are a lean and nimble organization with a proven management team."
President of DARA BioSciences Discusses Unique
Business Model at Collins Stewart Conference
The President, COO and Chief Scientific Officer of DARA BioSciences, Inc. (DARA), John Didsbury, Ph.D., presented Thursday at the Collins Stewart’s 4th Annual Growth Conference in New York, NY. DARA Bio- Sciences is a development-stage pharmaceutical company that acquires and develops promising drug candidates. DARA focuses its therapeutic development efforts on small molecules from late preclinical development through phase 2 clinical trials. DARA has a portfolio of therapeutic candidates for neuropathic pain, type 2 diabetes, and psoriasis. Dr. Didsbury explained at the conference, "We are executing a unique pharmaceutical product development business model. This model is designed to maximize returns to shareholders, minimize risk, and dramatically reduce the revenue generation time frame in the pharmaceutical industry sector." "We develop drugs that address large markets. We are very product-focused, beginning with identified drug molecule candidates with strong patent production. We are reducing product development risks.We are opportunistic and not therapeutically-focused. We are also focused on the lower-cost, higher-return stages of development. These include late preclinical through to Ph IIa stages," added Dr. Didsbury. "Our corporate strategy is unique. We are not involved in early drug research, which has the highest risk. We also do not participate in Phase III studies, which incur the highest costs. We are very flexible, and we cut programs quickly that have adverse results. We don’t hang on to ‘dogs’." He concluded, "We have a clearly defined business strategy that addresses pharmaceutical pipeline gaps. We are not relying on one candidate or one therepeutic category. We have a diverse portfolio. We are a lean and nimble organization with a proven management team."
Today's Headlines
AGREES TO SELL DIVISION FOR $24.5M:
Trans-Lux Corporation (TLX) has reached an agreement to sell its Entertainment division to private equity firm Marwit Capital of Newport Beach, CA. The Entertainment division operates 10 theatres and 69 screens in New Mexico, Colorado, Arizona and Wyoming. The purchase price of $24.5 million includes the assumption of approximately $16.0 million in debt, and with potential additional purchase price of up to $2.3 million based on the performance of increased theater operations at the DreamCatcher Cinema, which just expanded from a six-plex to a 10-plex. Marwit Capital also has an option to purchase raw land from the Company in Silver City, New Mexico. The transaction is expected to close in July, subject to the purchaser obtaining certain bank and landlord consents, bank financing, release of the Trans-Lux entities from mortgages being assumed and completion of other customary conditions. If the transaction is not closed by August 31, 2008, the agreement may be canceled by either party.SIGNS TWO SUPPLY CONTRACTS: Chindex International, Inc. (
CHDX) has signed two contracts for the supply of EUR10.8 million of laboratory and hospital products to Centers for Disease Control in China’s Gansu and Inner Mongolia provinces. The projects were awarded to Chindex’s German subsidiary, Chindex China-Export GmbH, in late January, and the contracts were signed on Monday in a ceremony in Beijing attended by officials from the Chinese National Development and Reform Commission, Ministry of Finance, Ministry of Health, Ministry of Commerce, the German Embassy, and the German KfW Development Bank.RELEASES POSITIVE RESULTS IN PH 2 TRIAL: Repros Therapeutics Inc. (
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VG) has received approval of its first internally developed patent, called "Method and Apparatus for Placing a Long Distance Call Based on a Virtual Phone Number." The invention allows customers to use a virtual number to contact parties at distant locations without incurring long distance charges. A virtual number allows a Vonage customer to have a secondary number where they can be reached. For example, a Vonage customer can get a secondary phone number with the same area code as his mother, so when his mother tries to contact him, she can as a local call even if he lives across the country.BEGINS DOSING IN PH IIA TRIAL: Nile Therapeutics, Inc. (
NLTX) has dosed the first acute setting heart failure patient in its Phase IIa, multi-center, open-label, ascending dose clinical study of the company’s lead product candidate, CD-NP, a novel chimeric natriuretic peptide, in development for the treatment of acute decompensated heart failure. The primary objective of the Phase IIa study is to assess hemodynamic effects of intravenous infusions of CD-NP in patients with heart failure. Key assessments include measurement of pulmonary capillary wedge pressure (PCWP), plasma cGMP, a secondary messenger of the target receptor, blood pressure, heart rate, serum potassium and renal function. Nile expects up to 30 heart failure patients will be enrolled in the trial.ANNOUNCES ACQUISITION: American Reprographics Company (
ARP) announced the acquisition of the assets of The Blueprint Company ("TBC"), a provider of reproduction, document management and related services to the architectural, engineering and construction industry in Hawaii. Terms of the acquisition were not disclosed. TBC services all of Hawaii’s major islands and is headquartered on the island of Oahu, in Honolulu. The acquisition established a leading position in major metropolitan, but it also helps close the geographical gap between the Company’s U.S.-based operations, eastern Asian markets, and UDS, ARC’s joint venture with Beijing-based Unisplendour in China.
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