MGI, SuperGen get nod from FDA for Dacogen; Impax stock climbs on FDA OK of generic Colestid

By Sheri Kasprzak

New York, May 3 - MGI Pharma Inc.'s shares advanced Wednesday after the Food and Drug Administration approved the jointly developed Dacogen for injection and another FDA approval sent Impax Laboratories, Inc.'s stock up as well.

Even though MGI's stock gained 4.84%, or 89 cents, to close at $19.28 (Nasdaq: MOGN), SuperGen, Inc., the joint developer of Dacogen, saw its stock dip 16 cents, or 2.97%, to settle at $5.22 (Nasdaq: SUPG). In premarket activity, though, SuperGen's stock had gained 17 cents at 9 a.m. ET. MGI's gains started early with the stock gaining 41 cents in premarket at 9 a.m. ET.

Dacogen is used to treat patients with myelodysplastic syndromes. The drug will be commercially available, according to MGI, in the second quarter of 2006.

According to the results from the phase 3 trial of Dacogen, 21% of the patients treated over two or more cycles demonstrated an overall response compared to a 0% response rate from patients who received only supportive care. All of the patients, a statement from MGI said Wednesday morning, remained independent of transfusions after being treated with Dacogen.

SuperGen conducted a randomized open-label controlled trial evaluating 170 adult patients with myelodysplastic syndromes and 80% were randomized to Dacogen therapy and supportive care. Eighty-three of the test subjects received Dacogen therapy plus supportive care and 81 received supportive care alone.

MGI also is conducting a phase 3 trial on Dacogen for patients with acute myeloid leukemia.

"The FDA approval of Dacogen marks an important advancement for patients who suffer from MDS," said John Bennett, chairman of the Myelodysplastic Syndromes Foundation, in a news release. "Patients with this serious condition are often anemic, experience fatigue and weakness and, in certain cases with an increase in leukemic blast cells, MDS can result in bone marrow failure."

MGI, based in Minneapolis, develops treatments for cancer. SuperGen, located in Dublin, Calif., develops therapies used to treat solid tumors, hematological malignancies and blood disorders.

Impax stock gains 2%

In other FDA news, Impax Laboratories' stock edged up 2.03%, or 18 cents, to finish the day at $9.05 (OTCBB: IPXL) after the FDA approved the company's Abbreviated New Drug application for a generic version of Pfizer, Inc.'s Colestid product.

Colestid is used to lower lipid levels in patients with hypercholesterolemia.

According to a statement from Impax, the company plans to start marketing the generic version of Colestid soon.

Located in Hayward, Calif., Impax develops generic and branded controlled-release products.

Ziopharm raises $37 million from PIPE

Ziopharm Oncology, Inc. closed a $36,999,515 stock deal.

The company sold 7,991,256 shares at $4.63 each to ProQuest Investments; LBI Group, Inc. (an affiliate of Lehman Brothers); Emerging Technology Partners; Knott Partners; Panacea Asset Management LLC; Cycad Group; Henderson Global Investors; and Medical Biohealth Trends and VCH Expert Biotechs, both funds advised by Medical Strategy.

The investors received warrants for 2.4 million shares, exercisable at $5.56 each for five years.

Paramount BioCapital, Inc. and Griffin Securities, Inc. were the placement agents.

Proceeds from the deal will be used to advance the clinical development of the company's ZIO-101 and ZIO-201 products and phase 1 and 2 trials.

Ziopharm's stock climbed 5 cents to end at $5.25 (OTCBB: ZIOP).

"With this financial milestone, we are able to continue to develop efficiently our current, and newly identified, product candidates for better cancer therapies," said Jonathan Lewis, the company's chief executive officer, in a statement. "The strong demand from investors resulted in an oversubscribed financing. The support of investors with notable experience and success in the biotechnology industry is greatly appreciated."

New York-based Ziopharm develops a portfolio of products used to treat cancer.

Regeneron stock climbs on earnings

Regeneron Pharmaceuticals, Inc. reported its earnings for the first quarter and saw its stock rise in the process.

The stock gained 83 cents, or 5.72%, to close at $15.34 Wednesday (Nasdaq: REGN). By noon, the stock had gained 2.27%, or 33 cents.

For the first quarter, Regeneron reported a net loss of $20.4 million, compared with a net loss of $4.1 million for the same quarter of 2005.

Revenues for the first quarter of 2006 climbed to $18.2 million from $16.2 million for the first quarter of 2005.

Regeneron incurred operating expenses of $39.9 million for the first quarter of 2006, 10% lower than the operating expenses incurred for the same quarter of 2005.

Located in Tarrytown, N.Y., Regeneron develops therapies for cancer, eye diseases and inflammatory diseases.

CepTor stock jumps 19%

After announcing it may sell its business or merge with another company, CepTor Corp.'s stock climbed by 19.05% to end the day at $0.25 (OTCBB: CEPO).

The drug maker has retained Oppenheimer & Co. to explore strategic alternatives, according to a CepTor statement released Wednesday afternoon.

"CepTor ... announced today that it is exploring various strategic alternatives to enhance shareholder value, including the possible sale or merger of the company," the statement said in part.

Based in Hunt Valley, Md., CepTor develops cell-targeted products used to treat neuromuscular and neurodegenerative diseases, focused in particular on orphan diseases.

AngioDynamics lower ahead of follow-on

AngioDynamics, Inc. suffered a hit to its stock on Wednesday on word that the company is about to price a follow-on offering of 2.4 million shares.

The stock fell $1.03, or 3.47%, to close at $28.66 (Nasdaq: ANGO) on Wednesday, a day after the company filed an S-3 with the Securities and Exchange Commission announcing the proposed follow-on.

On Tuesday, when the follow-on deal was announced, the stock slipped 81 cents to close at $29.69.

One buysider said he wasn't certain when the follow-on offering was slated to price but noted that the company is a strong one.

"I think they'll manage it fine," he said. "Their [financials] are strong, they're a solid company. I imagine they'll be able price it reasonably."

RBC Capital Markets is the bookrunner for the deal with Canaccord Adams, First Albany Capital and KeyBanc Capital Markets as co-managers.

AngioDynamics plans to use the proceeds for possible acquisitions of complementary businesses and technologies, for working capital and for other general corporate purposes.

AngioDynamics, based in Queensbury, N.Y., develops therapeutic and diagnostic medical devices to treat peripheral vascular disease and other non-coronary diseases.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.