chronic lymphocytic leukemia

Antisoma buys Xanthus for $52M

Fri, 16 May 2008 06:59:56 -0400

Looking to boost its pipeline, the U.K.'s Antisoma is paying $52 million for Boston oncology company Xanthus Pharmaceutical. Antisoma gains three drug candidates:

Xanafide, which is in Phase III trial in secondary acute myeloid leukemia,
Oral fludarabine, which has been submitted to the FDA for marketing approval for the second-line treatment of chronic lymphocytic leukemia, and
the Flt3 program, which is in preclinical testing for non-oncology indications. Antisoma says it may out-license this drug.

The deal lessens Antisoma's dependence on ASA404, a non-small cell lung cancer treatment. Last year the company announced it would pit the drug against Roche and Genentech's Avastin in a late-stage trial. Glyn Edwards, CEO of Antisoma, said: "This is a transforming deal. Combining Antisoma and Xanthus produces a company with the critical mass and mature pipeline needed to become a major player in oncology."

- here's the release on the deal
- read the MarketWatch article for more

Cephalon, investors await FDA Treanda decision

Wed, 19 Mar 2008 07:59:54 -0400

After seeing its stock price shed about a third of its value since last summer, Cephalon is keeping its fingers crossed that tomorrow's scheduled regulatory decision on its cancer drug Treanda can turn things around. At least that's what the analysts are seeing. Some expect a sharp upturn if the agency approves Treanda for chronic lymphocytic leukemia.

"This is the first big step. It will be the foundation for our oncology business," Liz Barrett, vice president of Cephalon's oncology unit, told the Wall Street Journal. Analysts peg its potential in the neighborhood of $250 million a year. But Cephalon is also looking for additional approvals, including using the therapy as an add-on to Rituxan, which could make it a seven-figure market blockbuster.

- here's Cephalon's release
- read the report in the Wall Street Journal

Related Articles:
Cephalon, NitroMed make cuts jobs. Report
Positive Phase III results for Cephalon's Treanda. Report
Cephalon takes heat for off-label narcotic promotion. Report
Cephalon shares tank after Sparlon rejection. Report

FDA extends review time for Genta's appeal

Mon, 14 Jan 2008 06:59:54 -0500

Genta is going to have to wait a little longer before it gets final word on its appeal of the FDA's rejection of Genasense. The feds were supposed to act by the end of last year, but Genta says now that a decision won't be made until sometime in the current quarter. Genta had filed for approval to use Genasense with chemotherapy in patients with relapsed or refractory chronic lymphocytic leukemia.

- check out the release on the appeal

Related Articles:
FDA rejects Genasense. Report
Advisory committee rejects Genta cancer drug. Report
Genasense hits primary endpoint in late-stage cancer trial. Report

Santaris grabs $30M in third round venture cash

Tue, 18 Dec 2007 06:59:54 -0500

Denmark's Santaris Pharma has banked $30 million from its latest venture round. Gilde Healthcare Partners put up much of that money with BankInvest, Novo, LD, Forbion Capital Partners, Global Life Science Venture, Sunstone Capital, Seventure, Omega, Innovation Capital and members of the company's board and management joining in.

Santaris has been studying RNA antagonist drug candidates based on its LNA chemistry. In 2008 the company said it expects to advance its SPC2996 compound, an RNA antagonist of Bcl-2, into Phase II clinical trials in chronic lymphocytic leukemia and B-cell lymphoma and initiate phase I volunteer studies of two new RNA antagonists for metabolic disorders.

- check out the release for more info

Related Articles:
Santaris inks $200M collaboration with Enzon. Report
Santaris Pharma pockets $48.3M in VC. Report

ALSO NOTED: Osiris shares jump on therapy results; Genmab recruits patients for leukemia study; Biocompatibles to launch stem c

Wed, 28 Nov 2007 06:59:50 -0500

> The international relief agency Oxfam lays the decline in pharma's overall stock performance at the developing world's doorstep. Investors know that emerging markets are key to the industry's growth, and Big Pharma is doing a lousy job in those markets, the agency contends. Report

> Shares of Osiris Therapeutics jumped 15 percent yesterday after the developer announced that its adult stem cell therapy for osteoarthritis produced "clinically and statistically significant" results over the past year. Report

> Denmark's Genmab has recruited 132 patients for a pivotal study of ofatumumab (HuMax-CD20(R)) for the treatment of refractory chronic lymphocytic leukemia. Release

> Biocompatibles International has received a green light from German regulators to start a trial of its stem cell therapy for hemorrhagic stroke. Report

> Pfizer and Nigeria's settlement talks in the litigation over a meningitis drug trial have broken down, government attorneys said. Report

> Big happenings in FDA Advisory Panel land today: The pediatrics committee is looking at GlaxoSmithKline's asthma drugs Serevent and Advair, while another panel preps for a closer look at Abbott's proposed drug-coated stent, Xience. Report

> Connecticut's decision to funnel $100 million into embryonic stem cell research has fueled a host of research programs in the state. Report

> Scientists at the University of Oxford are preparing clinical trials to test a new way to treat kidney and liver tumors. Ultrasound waves will be directed to tumors, where bubbles will develop and pop, releasing heat and killing cancer cells. Report

And Finally... The anti-smoking drug Champix has been linked to suicidal feelings. Report

Positive Phase III results for Cephalon's Treanda

Wed, 24 Oct 2007 06:59:57 -0400

Cephalon is touting Phase III results of its non-Hodgkin's lymphoma drug Treanda. In the trial, 100 patients who were not responding to Genentech and Biogen Idec's Rituxan were given Treanda. The overall response rate was 75 percent and the median duration of response was 40 weeks (9.2 months). The study met its primary endpoints of overall response rate and median duration of response, while demonstrating a manageable tolerability profile.

"We are encouraged that these results replicate those seen in our Phase 2 study, confirming the substantial efficacy in this difficult to treat population," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "Based on these positive results, we are on track to file a New Drug Application in the fourth quarter for Treanda in patients with indolent NHL who have failed treatment with rituximab." Treanda is also being studied as a treatment for chronic lymphocytic leukemia.

- see this release for more

PLUS: Anthera Pharmaceuticals has reported positive results from a Phase II clinical trial of its first compound, A-002, for the treatment of cardiovascular disease. Release

Related Articles:
Cephalon takes heat for off-label narcotic promotion. Report
Cephalon shares tank after Sparlon rejection. Report

DEALS: AstraZeneca, BMS ink diabetes drug pact

Wed, 17 Jan 2007 19:01:32 -0500

AstraZeneca, BMS ink diabetes drug pact

DEALS
WHO	WITH	WHAT	SCOOP
AstraZeneca	Bristol-Myers Squibb	$1.05B deal	AZ has agreed to pay BMS $100M up front and up to $950M more in milestones to partner up on two new diabetes drugs, saxagliptin and dapagliflozin.
Genentech	Seattle Genetics	$860M development deal	The deal is for SGN-40, a early-stage cancer treatment being studied for multiple myeloma, chronic lymphocytic leukemia and non-Hodgkin's lymphoma.
Eli Lilly	OSI	$385M licensing deal	OSI has licensed the exclusive rights to PSN010--its early-stage diabetes drug--to Eli Lilly for $25 million up front and up to $360 million in milestones plus royalty payments.
Genentech	BioInvent	$190M licensing deal	The deal is for BioInvent's BI-204, a preclinical therapy for reducing arterial plaque.
XTL Biopharmaceuticals	DOV Pharmaceutical	$134M licensing deal	XTL Biopharmaceuticals is licensing DOV Pharmaceuticals' rights to bicifadine as a treatment for neuropathic pain.
Biogen Idec	Syntonix Pharmaceuticals	$120M deal	Biogen gains a lead product for hemophilia B and technology for developing inhalable treatments.
Eli Lilly	Nicholas Piramal India	$100M development pact	Nicholas Piramal will advance some of Lilly's preclinical drug candidates in clinical trials in exchange for up to $100 million in milestones and a share of the royalties.
Health and Human Services	GlaxoSmithKline	$63.3M	GSK has won a $63.3 million contract from HHS to develop pre-pandemic and pandemic vaccines, supporting its research into adjuvants that boost the effectiveness of vaccines.
Pfizer	Genizon BioSciences	Licensing deal	Pfizer has licensed the diagnostic rights involved in the genetic research of Genizon BioSciences in Alzheimer's, ADHD, and endometriosis.
Wyeth Pharmaceuticals	Pharmacopeia	Development deal	Wyeth has inked a pact for Pharmacopeia's JAK3 inhibitor program, which focuses on the activation of T-cells for rheumatoid arthritis, psoriasis and other immunological conditions.
Wyeth Pharmceutical	Solvay	Development deal	Solvay and Wyeth Pharmceutical are expanding their existing neuroscience co-development and co-commercialization agreement to include research in neuroscience.
Pfizer	Archemix	Discovery pact	Archemix has agreed to employ its know-how in discovering aptamer-based drugs for Pfizer.

Press Release: Genentech and Seattle Genetics Announce Exclusive Global Licensing Agreement for SGN-40

Maureen Martino — Mon, 08 Jan 2007 12:43:46 -0500

Genentech and Seattle Genetics Announce Exclusive Global Licensing Agreement for Development and Commercialization of SGN-40
Seattle Genetics to Hold Conference Call Today at 4:30 p.m. ET

SOUTH SAN FRANCISCO, Calif. & BOTHELL, Wash. -- Genentech and Seattle Genetics, Inc. today announced that they have entered into an exclusive worldwide license agreement for the development and commercialization of SGN-40. SGN-40 is a humanized monoclonal antibody currently in Phase I and Phase II clinical trials for multiple myeloma, chronic lymphocytic leukemia and non-Hodgkin’s lymphoma.

Under the terms of the agreement, Seattle Genetics will receive an upfront payment of $60 million, potential milestone payments exceeding $800 million and escalating double-digit royalties on annual net sales of SGN-40. The milestone payments, which are dependent upon clinical and regulatory events across multiple disease indications worldwide, as well as attainment of certain annual net sales levels, include $20 million in committed payments during the first two years of the agreement. Genentech will fund future research, development, manufacturing and commercialization costs. Seattle Genetics will continue certain Phase I and Phase II clinical trials and development activities, the costs of which will be reimbursed by Genentech. Seattle Genetics also has an option for co-promotion rights on SGN-40 in the U.S. The completion of the agreement may be subject to Hart-Scott-Rodino approval under United States antitrust laws and customary closing conditions.

“This alliance enables us to accelerate and expand development of SGN-40 while we continue to advance our other promising clinical and preclinical development programs,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Genentech’s oncology development expertise, commercial leadership and history of successful strategic alliances make it an ideal collaborator to bring the potential benefits of SGN-40 to patients.”

"We are very interested in the encouraging activity of SGN-40 observed in early clinical trials and we look forward to developing this antibody with Seattle Genetics, in addition to continuing our ongoing collaboration on antibody-drug conjugates," said Hal Barron, M.D., senior vice president, Development and chief medical officer for Genentech. "SGN-40 supports our commitment to developing new hematology therapeutics that may provide novel treatment approaches for a variety of serious hematologic diseases."

About SGN-40

SGN-40 is a humanized monoclonal antibody that targets the CD40 antigen, which is highly expressed on most B lineage hematologic malignancies including non-Hodgkin's lymphoma, multiple myeloma and chronic lymphocytic leukemia. CD40 is also found on many types of solid tumors, including bladder, renal and ovarian cancer, and may play a role in immunologic diseases.

Positive Phase I data were reported last month at the annual meeting of the American Society of Hematology demonstrating that SGN-40 is well tolerated and induces objective antitumor activity in patients with relapsed or refractory non-Hodgkin’s lymphoma. Based on these results, Seattle Genetics initiated a single-agent Phase II study designed to assess the antitumor activity, tolerability and pharmacokinetic profile of SGN-40 in patients with relapsed or refractory diffuse large B-cell lymphoma in December 2006. In addition, SGN-40 is being evaluated in Phase I clinical trials for relapsed or refractory multiple myeloma and chronic lymphocytic leukemia.

Conference Call Details

Seattle Genetics’ management will host a conference call and webcast to further discuss the agreement. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event will be available from the Seattle Genetics website at http://www.seattlegenetics.com, under the News and Investor Information section, or by calling (800) 218-8862 (domestic) or (303) 262-2175 (international). A replay of the discussion will be available beginning at approximately 3:30 p.m. PT today from Seattle Genetics’ website or by calling (800) 405-2236 (domestic) or (303) 590-3000 (international), using passcode 11081068. The telephone replay will be available until 6:00 p.m. PT on Friday, January 12, 2007.

About Seattle Genetics

Seattle Genetics is a biotechnology company developing monoclonal antibody-based therapies for the treatment of multiple types of cancer, including non-Hodgkin's lymphoma, multiple myeloma, acute myeloid leukemia and Hodgkin's disease. The company has also developed proprietary antibody-drug conjugate (ADC) technology comprised of highly potent synthetic drugs and stable linkers for attaching the drugs to monoclonal antibodies. In addition to its worldwide development agreement for SGN-40 with Genentech, Seattle Genetics currently has license agreements for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Genentech, Bayer, CuraGen, Progenics and MedImmune. More information can be found at http://www.seattlegenetics.com.

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.

Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the therapeutic benefit and future advancement of SGN-40 by Seattle Genetics or Genentech. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks related to adverse clinical results as SGN-40 advances in clinical trials, such as patients exhibiting progressive disease or severe adverse events, as well as the inability to achieve certain milestones or net sales levels. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company’s filings with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

This press release contains a forward-looking statement regarding the development of SGN-40. Such statement is a prediction and involves risks and uncertainties such that the actual result may differ materially. Among other factors, the development of SGN-40 could be affected by a number of factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the need for additional clinical studies, intellectual property or contract rights, FDA actions or delays, the failure to obtain or maintain FDA approval. Please also refer to Genentech’s periodic reports filed with the Securities and Exchange Commission. Genentech disclaims, and does not undertake, any obligation to update or revise the forward-looking statement in this press release.

Seattle Genetics shares soar on Genentech pact

Sun, 07 Jan 2007 19:01:38 -0500

Shares of Seattle Genetics shot up 31.5 percent this morning after it announced that it would gain $60 million up front and more than $800 million in potential milestones from Genentech from its newly signed development pact for SGN-40. Genentech is committed to pay $20 million of those milestones payments in the first two years of the agreement as Seattle Genetics is reimbursed for clinical trials. The therapy is an early-stage cancer treatment being studied for multiple myeloma, chronic lymphocytic leukemia and non-Hodgkin's lymphoma.

- check out the release on the deal with Genentech

ALSO: Seattle Genetics has also signed a joint research agreement with Agensys to develop antibody-drug conjugate therapies for cancer. Release

Related Article:
Genentech inks $300M pact with Swiss biotech. Report
Genentech strikes $919M deal to buy Tanox. Report

Press Release: GSK and Genmab sign $2.1B deal for HuMax-CD20

Maureen Martino — Tue, 19 Dec 2006 08:45:14 -0500

GlaxoSmithKline and Genmab Enter Global Agreement For HuMax-CD20

LONDON, PHILADELPHIA, and COPENHAGEN, Denmark, Dec. 19 -- GlaxoSmithKline (GSK) and Genmab A/S today announced a worldwide agreement to co-develop and commercialize HuMax- CD20(TM) (ofatumumab), a fully human monoclonal antibody in late stage development for CD20 positive B-cell chronic lymphocytic leukemia (B-CLL) and follicular non-Hodgkin's lymphoma (NHL) and in Phase II for rheumatoid arthritis (RA).

Under the terms of the agreement, Genmab will receive a license fee of DKK 582 million (approximately 52 million pounds Sterling and approximately $102 million*), and GSK will invest DKK 2,033 million (approximately 183 million pounds and approximately $357 million) to purchase, 4,471,202 ordinary shares of Genmab. The total potential value of this agreement, in the event of full commercial success, in cancer and various autoimmune and inflammatory diseases, could exceed DKK 12.0 billion (approximately 1.1 billion pounds and approximately $2.1 billion), including the initial license fee and equity purchase, milestone payments, totaling DKK 9.0 billion (approximately 0.8 billion pounds and approximately $ 1.6 billion) and expected development, commercial manufacturing and commercialization costs.

In addition, Genmab will be entitled to receive tiered double digit royalties on global sales of HuMax-CD20.

GSK will receive an exclusive worldwide license to HuMax-CD20 as well as any other antibodies with affinity for the CD20 antigen which Genmab may develop. GSK will also have an exclusive option to a CD20 UniBody(TM) to be developed in collaboration with Genmab. GSK and Genmab will co-develop HuMax- CD20. Genmab will be responsible for development costs until 2008, including costs of the two ongoing late stage oncology studies after which development costs will be shared equally between GSK and Genmab. GSK will be solely responsible for the manufacturing and commercialization of HuMax-CD20.

Genmab will have an option to co-promote HuMax-CD20 in a targeted oncology setting in the US and in the Nordic region. Should this be undertaken, Genmab will also have the option co-promote Bexxar(TM) and Arranon(TM) in the US and Atriance(TM) in the relevant countries of the Nordic region.

The agreement is subject to review by the US Government under the Hart- Scott-Rodino Act and will become effective after clearing review.

Dr. Moncef Slaoui, Chairman of Research and Development, GSK, commented, "We believe that this alliance is a significant step for GSK and Genmab. By combining the skills and knowledge of Genmab in developing fully human antibodies, such as HuMax-CD20, and the substantial experience of GSK in clinical and commercial development, we hope to be able to bring this innovative and potentially valuable medicine to patients as soon as possible."

"This alliance puts the tremendous strength of GSK's development, sales and marketing expertise behind HuMax-CD20," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We are looking forward to our collaboration and working together to maximize the value of this product that has the potential to benefit so many patients with different diseases."

Conference Call

Genmab will hold a conference call about the news today, December 19th at

3:30 PM CET
2:30 PM GMT
9:30 AM EST

The dial in numbers are as follows:
+1 800 475 3716 (in the US)
+1 719 457 2728 (outside the US)

The conference call will be held in English.

To listen to a live webcast of the call please visit: https://cis.premconf.com/sc/scw.dll/usr?cid=vlllrcrwwszvmlnx

Simultaneously with this release, Genmab will publish a separate stock exchange release containing more information regarding the placement of Genmab shares to GSK which is made in direct connection with the global development and commercialization agreement regarding HuMax-CD20.
About HuMax-CD20 (ofatumumab)

HuMax-CD20 is a fully human antibody which binds to the CD20 antigen on the surface of B-cells, white blood cells that normally play a positive role in the immune system. Since certain lymphomas and leukemias arise from the same sources as white blood cells, these cancers frequently have CD20 on the surface. When HuMax-CD20 binds to CD20 the antibody recruits the body's natural defenses to attack and kill these selected cells, which can be implicated in various forms of cancer, autoimmune and inflammatory diseases. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months. Mature B-cells, known as plasma cells, which produce antibodies that support immunity do not carry the CD20 marker and are thus also spared to continue their vital role.

About CLL, NHL and RA

CLL is the most common leukemia in adults in the US and most of Western Europe. The incidence is 8,100 to 12,500 new cases in the US per year and 85- 95% of the cases are of B-cell origin.

CLL is a subgroup of non-Hodgkin's lymphoma (NHL) and together with small lymphocytic lymphoma (SLL) corresponds to around 20% of all NHL cases.

The incidence of NHL in the US is approximately 54,000 new cases per year, accounting for approximately 5% of all US cancer deaths. Follicular lymphoma (FL) is a subgroup of NHL. FL is the second most common lymphoma in the US and Europe, accounting for 11 to 35% of all NHL.

RA is a systemic inflammatory disease which affects 0.8-1% of all populations, approximately 2 million people in the US alone. B-cells are crucial pathogenic elements in the induction and development of RA. As B- cells are involved in various cellular interactions with immune cells, B-cell depletion after HuMax-CD20 treatment may diminish RA disease activity.

The Global Co-Development and Commercialization Agreement regarding HuMax- CD20 including the Private Placement to GlaxoSmithKline will not affect the Company's financial guidance for 2006. The impact on 2007 will be included in the Company's financial guidance for 2007.

* Figures based on an exchange rate of 11.0992 from Danish kroner to Pounds sterling and an exchange rate of 5.6920 from Danish kroner to US dollars as of December 18th 2006.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information, visit GlaxoSmithKline on the World Wide Web at http://www.gsk.com.

About Genmab A/S

Genmab A/S is a biotechnology company that creates and develops human antibodies for the treatment of life-threatening and debilitating diseases. Genmab has numerous products in development to treat cancer, infectious disease, rheumatoid arthritis and other inflammatory conditions, and intends to continue assembling a broad portfolio of new therapeutic products. At present, Genmab has multiple partnerships to gain access to disease targets and develop novel human antibodies including agreements with Roche and Amgen. A broad alliance provides Genmab with access to Medarex, Inc.'s array of proprietary technologies, including the UltiMAb® platform for the rapid creation and development of human antibodies to virtually any disease target. In addition, Genmab has developed UniBody(TM), a new proprietary technology that creates a stable, smaller antibody format. Genmab has operations in Europe and the US. For more information about Genmab, visit http://www.genmab.com.

This press release contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. Genmab is not under an obligation to up-date statements regarding the future following the publication of this release; nor to confirm such statements in relation to actual results, unless this is required by law.

GlaxoSmithKline Forward-Looking Statements

Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report on Form 20-F for 2005.
Genmab®; the Y-shaped Genmab logo®; HuMax®; HuMax-CD4®; HuMax- EGFr(TM); HuMax-Inflam(TM); HuMax-CD20(TM); HuMax-TAC(TM); HuMax-HepC(TM), HuMax-CD38(TM); and UniBody(TM) are all trademarks of Genmab A/S.

UltiMAb® is a trademark of Medarex, Inc.

Glaxo forges $2.1B deal for HuMax-CD20

Mon, 18 Dec 2006 19:01:38 -0500

Denmark's Genmab will gain up to $2.1 billion in a licensing deal with GlaxoSmithKline for the HuMax-CD20 antibody for leukemia, far outstripping the numbers predicted by analysts. Genmab will get $102 million up front, a 10 percent equity investment worth $357 million and up to $1.6 billion in milestone payments. The therapy is in a late-stage trial for chronic lymphocytic leukemia and non-Hodkin's lymphoma and in mid-stage trials for rheumatoid arthritis and new cases of lymphocytic leukemia. Genmab has forecast that HuMax-CD20 will gain regulatory approval in 2008 and has projected top annual sales of $2 billion. Analysts say that this is the biggest licensing deal on record, surpassing the $2 billion deal for Erbitux which was later scaled down.

GlaxoSmithKline has been on a buying spree recently, inking the acquisition of Domantis while executing a string of licensing deals. Altogether, Glaxo has committed up to $4 billion in the last two weeks to buyouts and development pacts. Glaxo is putting the market on notice that it is bullishly stuffing its pipeline with some of the brightest therapeutic hopes tracked around the globe as it prepares to lose patent control of its blockbusters.

- check out the release for more information
- read the report on the deal from the International Herald Tribune

Related Articles:
Genmab shares up on new antibody tech. Report
Glaxo to buy Domantis for $453M. Report
Epix shares soar on $1.2B pact with GSK. Report

Press Release: Genta Receives Non-Approvable Notice for Application of Genasense

Maureen Martino — Thu, 14 Dec 2006 10:24:28 -0500

Genta Receives Non-Approvable Notice for Application of Genasense in Patients With Chronic Lymphocytic Leukemia

BERKELEY HEIGHTS, N.J., Dec. 15 -- Genta Incorporated (Nasdaq: GNTA - News) today announced that the Company has received notice that its New Drug Application (NDA) for the use of Genasense plus chemotherapy in patients with chronic lymphocytic leukemia (CLL) has been deemed non-approvable by the Food and Drug Administration.

We are keenly disappointed by this decision," said Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "We believe that Genasense has amply demonstrated its efficacy and safety in patients with relapsed and refractory CLL in a carefully designed and executed randomized clinical trial. As we decide on next steps with this application, we will continue working to seek worldwide approval of Genasense for patients who have advanced cancer."

About Genasense

Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.

About Genta

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company's research platform is anchored by two major programs that center on oligonucleotides (RNA- and DNA- based medicines) and small molecules. Genasense® (oblimersen sodium) Injection is the Company's lead compound from its oligonucleotide program. Genta has completed a pending Marketing Authorization Application to the European Medicines Agency (EMEA) for use of Genasense plus dacarbazine for treatment of patients with advanced melanoma. The leading drug in Genta's small molecule program is Ganite® (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: www.genta.com.

Safe Harbor

This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Forward- looking statements include, without limitation, statements about:

* the Company's ability to obtain necessary regulatory approval for Genasense® from the U.S. Food and Drug Administration ("FDA") or European Medicines Agency
* the safety and efficacy of the Company's products or product candidates;
* the Company's assessment of its clinical trials;
* the commencement and completion of clinical trials;
* the Company's ability to develop, manufacture, license and sell its products or product candidates;
* the Company's ability to enter into and successfully execute license and collaborative agreements, if any;
* the adequacy of the Company's capital resources and cash flow projections, and the Company's ability to obtain sufficient financing to maintain the Company's planned operations;
* the adequacy of the Company's patents and proprietary rights;
* the impact of litigation that has been brought against the Company and its officers and directors;
* the Company's ability to regain compliance with the NASDAQ's listing qualifications; and
* the other risks described under Certain Risks and Uncertainties Related to the Company's Business, as contained in the Company's Annual Report on Form 10-K and Quarterly Report on Form 10-Q.

The Company does not undertake to update any forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2005 and its most recent quarterly report on Form 10-Q.

Protherics selling shares to finance new deals

Wed, 06 Dec 2006 19:01:36 -0500

The U.K.'s Protherics has inked a trio of deals aimed at boosting its pipeline. It's agreed to pay $25 million to buy MacroMed in order to obtain OncoGel for esophageal and brain cancers; acquired technical knowledge from Glenveigh Pharmaceuticals on the use of sheep polyclonal antibodies to treat pre-eclampsia and eclampsia; and licensed a drug for B-cell chronic lymphocytic leukemia from Advanced In Vitro Cell Technologies. To finance the deals, Protherics is offering shares worth about $75 million. Protherics has been hampered by delays in developing its two main drug therapies.

- here's the AFX report on Protherics

Related Articles:
Protherics shares soar on $338M licensing pact. Report

Advisory committee rejects Genta cancer drug

Wed, 06 Sep 2006 20:01:38 -0400

The FDA's advisory committee for cancer drugs turned thumb's down on Genta's cancer therapy Genasense on Wednesday, voting seven to three to recommend against approval. The news was no surprise and investors bailed before the vote was ever taken, sending shares down 38 percent in advance of the advisory committee meeting. The therapy was intended to treat refractory chronic lymphocytic leukemia, in conjunction with chemotherapy but data from a pivotal trial failed to impress a majority of the committee. In a trial, 17 percent of volunteers responded to the combinational therapy compared to seven percent receiving chemo alone. Genta, though, says it isn't retreating.

"While we are disappointed with today's outcome, we strongly believe in the potential of Genasense and what it may offer patients with advanced cancer," said Dr. Raymond P. Warrell Jr., Genta's chief executive, in a statement. "We remain committed to the development of this agent and will continue working with FDA regarding their review of this application."

- read the AP's report on Genta

Genasense hits primary endpoint in late-stage cancer trial

Sun, 18 Sep 2005 20:01:37 -0400

Genta stock surged on the news that an extended follow-up of its Phase III trial of its oncology drug Genasense--in combination with chemotherapy--demonstrated positive data for keeping patients in remission and reducing the number of relapses for chronic lymphocytic leukemia. The trial achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (17 percent vs. 7 percent, respectively). Genta says it should be able to file for marketing approval by the end of the year as planned, and it is in talks with the FDA on designing a Phase IV post-marketing trial. Genta plans to request an accelerated approval of the drug.

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Leukemia patients demonstrate high response rate to Genmab drug

Thu, 15 Sep 2005 20:01:38 -0400

Interim results for a Phase I/II study of Genmab's HuMax-CD20 found a statistically significant reduction in leukemia cells in patients with relapsed chronic lymphocytic leukemia. A response rate of 52 percent -- 12 out of 23 patients -- responded at the highest dose level after 11 weeks of treatment. That broke down to a complete response of 22 percent and a partial response of 30 percent. After the fourth and final treatment, all patients treated at the highest dose level (2000 mg) experienced pronounced leukemia cell depletion.

"We are encouraged by the results seen in this study so far," said Lisa N. Drakeman, Ph.D., CEO of Denmark's Genmab. "The data supports continuing the development of HuMax-CD20 for CLL."

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VC: Gemin X leads with $65M second round

Wed, 01 Jun 2005 20:01:32 -0400

Gemin X leads with $65M second round.

VENTURE CAPITAL
COMPANY	AMOUNT/ROUND	LEAD INVESTORS	DESCRIPTION
Gemin X Montreal	$65.2M second round	H.I.G., Sanderling	Funding will support Gemin X's continued clinical development of lead product candidate GX15-070, including an ongoing Phase I/II trial in patients with chronic lymphocytic leukemia and a Phase I trial in patients with solid tumors.
Oxagen Abingdon, UK	$59.8M second round	MPM Capital	The funds will advance Oxagen's small molecule anti-inflammatory for asthma to the clinic and expand the company's clinical and pre-clinical stage portfolio.
Phenomix San Diego	$40M second round	JPMorgan Partners, Delphi Ventures	The money will allow Phenomix to steer its lead drug into human trials.
Cylene Pharmaceuticals San Diego	$26.3M second round	Coastview Capital	The funding will allow Cylene to advance CX-3543, its lead product for the treatment of multiple cancers, into clinical development.
Aperon Biosystems Palo Alto, CA	$15.3M second round	Canaan Partners	Aperon is developing an in-home monitor for daily measurement of exhaled nitric oxide for the management of asthma.
Innovative Biosensors College Park, MD	$3.5M first round	Harbert Venture Partners	Innovative Biosensors is developing technologies for the rapid detection of pathogens.