Dyax Corp. (DYAX)

[senderos]

I still don't see why this dropped today.

[surf1944]

http://www.insidercow.com/history/company.jsp?company=dyax&B1=Search!

[surf1944]

http://www.secform4.com/insider-trading/907562.htm

[surf1944]

http://www.nasdaq.com/asp/holdings.asp?symbol=DYAX&selected=DYAX&FormType=Institutional

[senderos]

It seems clear to me that this stock just has not been discovered yet. Now is the time to take advantage of that.

[krumbz72001]

I bought into this one snbout a month ago after some reasearch and then when I saw all the insider buying through the past year that sold me. Wish I would have bought more at 1.66 but I still my add on a few more shares I like this one for the long haul. Plus with all the insider buying they must be pretty confident. Good luck all hope it keeps going up!

[senderos]

Another nice move here today.

[senderos]

Tomorrow, DYAX has an earnings CC. But why would a company have one 3 weeks after they filed their quarterly earnings report?

[senderos]

This has been trading better the past few days. Seems to be consolidating in the 1.90-2.0 range. Just a matter of time until the potential of this one is realized by the market, IMO. Worth checking out their pipeline.

[Hostile Takeover]

Thanks, hopefully you can help with the DD along the way.

That is why I landed here.

They have some momentum going with their progress.

GLTA investors.

HT

[senderos]

I just double-checked their website. If you count all compounds in Phase trials, including their own testing and that of their licensees, they have 24 trials ongoing in Phase 1-3. Very impressive.

Start here:

http://www.dyax.com/products-and-pipeline/products.html

[Hostile Takeover]

We will continue to post together and hopefully become profitable watching them become helpful to the one's that really need them.

HT

[senderos]

I'm very patient. This is one of those stocks I have put away.

[Hostile Takeover]

This stock is definitely gaining momentum. If your spirit allows, be patient. I'll stay active on this.

[senderos]

I bought this a couple of weeks ago after doing my DD. About 81% of the O/S shares are owned by institutions and insiders, it has enough cash to take it through 2012, and the pipeline is very strong. By my count, it has 18 Phase 1-3 trials ongoing, and one drug at commercial stage. I can not understand why I am not seeing more buzz about this one.

[Hostile Takeover]

I shall continue the DD.

[Hostile Takeover]

A very positive looking penny IMO.

[Hostile Takeover]

Another speculative buy for my portfolio.

[Hostile Takeover]

The Company commercializes KALBITOR on its own in the United States. In addition to its approved commercial use for HAE in the United States, the Company is also developing DX-88 through collaborations in other indications. These include use of DX-88 for the reduction of blood loss during surgery in collaboration with Cubist Pharmaceuticals (Cubist), and for treatment of retinal diseases in collaboration with Fovea Pharmaceuticals (Fovea), which was acquired by sanofi-aventis during the year ended December 31, 2009.

[senderos]

Awfully dead here. Why? I just started looking hard at this one.

[surf1944]

4:09PM Dyax reports Q4 loss per share of (0.09) vs. ($0.11) Thomson Reuters consensus; revenue increased 47.6% y/y to $9.3 mln vs. $8.04 mln consensus (DYAX) 1.85 -0.06 : Co issues guidance for FY11, sees revenue of $38-$44 mln vs. $52.68 mln Thomson Reuters consensus. Expects to be cash flow breakeven in 2013, and have GAAP positive earnings in 2014.

[surf1944]

She reaffirmed a "Outperform" rating and $8 price target on Dynavax Technologies Corp. citing the potential for positive data from a late-stage study on the company's potential hepatitis B drug.

http://finance.yahoo.com/news/WedBush-Handful-of-biotechs-apf-3541560572.html?x=0&.v=1

[DOLLARLAND]

I don't know a thing about this company, but the chart looks ripe for a turn north, imo.

Rhino

[surf1944]

Dyax DYAX Caris & Company Average $2.87

with a specific price point, I quess this anal-list wants you to believe is actually knows his stuff....right

[dianebRN]

Thanks for the info bimmer. I saw it as well. Angioneurotic edema (lot of people leave out the neurotic part but I believe it was an official name before Angioedema) such a rare disease that the treatment is undervalued. Like many things in medicine, I believe it could serve as a bridge to other discoveries related to treatment of allergic responses etc. IMHO wait for scientists to connect the dots.

[B7$4]

"DYAX News" Data from First Phase 3 Trial (EDEMA3(R)) for KALBITOR(R) (ecallantide) Published in The New England Journal of Medicine

http://www.marketwatch.com/story/data-from-first-phase-3-trial-edema3r-for-kalbitorr-ecallantide-published-in-the-new-england-journal-of-medicine-2010-08-05?reflink=MW_news_stmp

CAMBRIDGE, Mass., Aug 05, 2010 (BUSINESS WIRE) -- Dyax Corp. /quotes/comstock/15*!dyax/quotes/nls/dyax (DYAX 2.55, +0.08, +3.24%) announced today that results from EDEMA3(R), the Company's first Phase 3 trial evaluating KALBITOR(R) (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE), were published in the August issue of The New England Journal of Medicine. KALBITOR, discovered and developed by Dyax, is available in the United States for the treatment of acute attacks of HAE in patients 16 years of age and older.

EDEMA3 was the first of two Phase 3 trials evaluating KALBITOR for the treatment of acute HAE attacks. Results showed a statistically significant improvement of HAE attack symptoms with KALBITOR treatment versus placebo.

"The KALBITOR clinical program, including EDEMA3 and EDEMA4(R), supports the treatment benefit of KALBITOR for HAE acute attacks," said H. Henry Li, MD, an author and Director of Immunology at the Institute for Asthma & Allergy in Wheaton, MD. "Moreover, the publication of these data will enhance understanding among the physician community about the value of KALBITOR's unique mechanism of action, as a selective plasma kallikrein inhibitor, in resolving acute HAE symptoms."

The overall safety profile of KALBITOR observed in EDEMA3 was similar to that of placebo. The most common adverse events occurring more often in KALBITOR-treated patients versus placebo were mild or moderate and included: headache, diarrhea, pyrexia and nasal congestion. Treatment-related adverse events and serious adverse events occurred at a similar proportion in both the KALBITOR- and placebo-treated groups.

EDEMA3 was a 72-patient, double-blind, placebo-controlled trial randomized 1:1 to receive a 30 mg subcutaneous dose of KALBITOR or placebo. Patients were observed for at least 4 hours after KALBITOR was administered. Symptoms were assessed every 15 minutes for the first two hours, every 30 minutes for the next two hours, and again at 24 hours.

EDEMA3 was the first study to assess treatment response with two HAE-specific patient-reported outcomes measures, which were developed and validated by Dyax. Prior to the EDEMA3 trial, there was no validated instrument to assess HAE symptom complexes. The Mean Symptom Complex Severity (MSCS) score provides a point-in-time measure of individual symptoms that accounts for symptom location and severity of the attack using a score from 0 to 3 (0=normal, 3=severe). The Treatment Outcome Score (TOS) provides a composite measure of treatment response on a scale of 100 to -100 (100=significant improvement, -100 significant worsening) and taking into account symptom severity at baseline.

The primary endpoint was the TOS at 4 hours after dosing with KALBITOR or placebo. The principal secondary endpoint was the change from baseline in MSCS at 4 hours. At 4 hours post treatment, statistically significant improvement of symptoms was demonstrated for KALBITOR versus placebo, as measured by both the median TOS (P=0.004) and the median change in MSCS score (P=0.01). Statistical significance in favor of KALBITOR treatment was also demonstrated at 24 hours for median TOS (P=0.007) and median change in MSCS score (P=0.04).

[surf1944]

UPDATE 1-Dyax posts narrower-than-expected Q2 loss

http://www.reuters.com/article/idCNSGE66R0H420100728?rpc=44

[surf1944]

Dyax Features Comprehensive Financial Assistance Program On Enhanced Product Website for KALBITOR® (ecallantide)

http://finance.yahoo.com/news/Dyax-Features-Comprehensive-bw-697627288.html?x=0&.v=1

[surf1944]

7:02AM Dyax announces Marketing Authorization Application for DX-88 validated by European Medicines Agency (DYAX) 2.27 : Co announces that the European Medicines Agency has completed its validation process for the Marketing Authorization Application for potential approval to market DX-88 in the European Union. The completion of this validation process signifies that the formal scientific review of the MAA has begun.

[surf1944]

6:32AM Dyax and Sigma-Tau announce partnership to develop and commercialize subcutaneous DX-88 for hereditary angioedema (DYAX) 2.68 : The co and Defiante Farmaceutica S.A., a subsidiary of the pharmaceutical company Sigma-Tau SpA, announced today a strategic partnership to develop and commercialize subcutaneous DX-88 for the treatment of hereditary angioedema and other therapeutic indications throughout Europe, North Africa, Middle East and Russia. Dyax retains its rights to subcutaneous DX-88 in other territories, including the U.S., where DX-88 has been approved by the U.S. Food and Drug Administration and is marketed as KALBITOR for the treatment of acute attacks of HAE in patients 16 years of age and older. Under the terms of the agreement, Sigma Tau will make a $2.5 mln upfront payment to Dyax and will purchase $2.5 mln in equity shares at a 50% premium above market value. Dyax will also be eligible to receive over $100 mln in development and sales milestones related to DX-88 and royalties equal to 41% of net sales of product.

[surf1944]

Dyax Announces Publication of KALBITOR® (ecallantide) EDEMA4® Trial Results in the Annals of Allergy, Asthma, and Immunology

http://finance.yahoo.com/news/Dyax-Announces-Publication-of-bw-374035026.html?x=0&.v=1

[surf1944]

Dyax DYAX Jefferies Buy $6

[surf1944]

Dyax Corporation Q1 2010 Earnings Call Transcript

http://seekingalpha.com/article/202159-dyax-corporation-q1-2010-earnings-call-transcript?source=yahoo

[surf1944]

7:30AM Dyax sells rights to Xyntha royalty stream to Paul Capital Healthcare for up to $12 million (DYAX) 1.46 : The co announces that it has sold its rights to royalties and other payments related to the commercialization of Xyntha by Pfizer (PFE), a licensee under the Company's phage display Licensing and Funded Research Program (LFRP), to an investment fund managed by Paul Capital Healthcare. Under the terms of this sale, Dyax received an upfront cash payment of $10 million and will be eligible to receive milestone payments totaling up to $2 million based on Xyntha sales in 2010 and 2011. A portion of the upfront cash payment was applied to Dyax's debt obligations under the LFRP and, net of this and other required payments, Dyax received approximately $6.8 million, exclusive of potential future milestone payments.

[surf1944]

Dyax Announces Pricing of Public Offering of Common Stock

Press Release Source: Dyax Corp. On Thursday March 25, 2010, 8:58 am
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ: DYAX - News) today announced the pricing of an underwritten public offering of 17,000,000 shares of its common stock at a price to the public of $3.25 per share. The gross proceeds from the sale of shares, after underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $51.8 million. The offering is expected to close on or about March 30, 2010, subject to customary closing conditions.

Jefferies & Company, Inc. is acting as the sole book-running manager of the offering with Needham & Company, LLC acting as the co-lead manager. Dyax has granted the underwriters a 30-day option to purchase up to 2,550,000 additional shares of common stock at the public offering price to cover over-allotments, if any.

Dyax intends to use the net proceeds from this offering to fund commercialization and distribution activities for KALBITOR® (ecallantide), our lead product for the treatment of acute attacks for hereditary angioedema, to fund other research and preclinical development activities, and for general corporate purposes.

A registration statement relating to the shares of Dyax common stock being offered has been filed with, and declared effective by, the Securities and Exchange Commission (the “SEC”). A preliminary prospectus supplement relating to the offering has also been filed with the SEC and is available on the SEC’s website at http://www.sec.gov. Copies of the final prospectus supplement and related prospectus, when available, may be obtained from Jefferies & Company, Inc., Attention: Syndicate Prospectus Department, 520 Madison Avenue, New York, NY, 10022 or at [phone]. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

[surf1944]

7:31AM Dyax reports KALBITOR data was presented at American Academy of Allergy, Asthma and Immunology meeting (DYAX) 3.61 : Data demonstrating the effectiveness of KALBITOR to treat hereditary angioedema acute attacks by primary attack location were provided in an oral presentation yesterday at the American Academy of Allergy, Asthma and Immunology 2010 Annual Meeting in New Orleans. KALBITOR, discovered and developed by DYAX, was approved by the FDA late last year and is indicated for the treatment of acute attacks of HAE in patients 16 years of age or older. Efficacy endpoints assessed at 4 hours post-dosing for peripheral, abdominal and laryngeal attacks included two, HAE-specific, patient-reported outcome measures: Mean Symptom Complex Severity score and Treatment Outcome Score. Time to significant improvement was also assessed at 4 hours.

[surf1944]

Dyax Corp. Announces Fourth Quarter and Year End 2009 Financial Results

Press Release Source: Dyax Corp. On Wednesday February 17, 2010, 7:30 am EST
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ: DYAX) today announced financial results for the fourth quarter and year ended December 31, 2009. Dyax will host a webcast and conference call at 10 a.m. (ET) this morning to review the financial results and corporate progress for the quarter.

Financial Results

Total revenues for the fourth quarter ended December 31, 2009 were $6.3 million, as compared to $31.5 million for the comparable quarter in 2008. Revenues for the year ended December 31, 2009 were $21.6 million, as compared to $43.4 million for the 2008 year. The higher 2008 revenue was primarily due to revenue recognized in relation to new license and collaboration agreements entered into during 2008, for which there was no corresponding revenue recognized in 2009. Quarterly revenues are expected to fluctuate due to the timing and amount of future milestone payments, the clinical activities of collaborators and licensees, and the timing and completion of contractual commitments.

Research and development expenses for the fourth quarter of 2009 decreased to $8.8 million, as compared to $16.4 million for the comparable quarter in 2008. For the year ended December 31, 2009, research and development expenses decreased to $46.6 million, as compared to $68.1 million for the comparable period in 2008. Research and development expenses decreased during the 2009 quarter due to cost savings resulting from the restructuring in March 2009, as well as decreases in manufacturing and other external research and development expenses. For the twelve month 2009 period, the decrease in research and development expenses was primarily due to lower clinical trials costs, the closure of the Company’s Liege, Belgium research facility in mid-2008, and cost savings resulting from the March 2009 restructuring. These decreases were offset by an increase of approximately $5.8 million in 2009 costs associated with the manufacture of DX-88 prior to FDA approval. With this supply of DX-88, the Company has sufficient commercial product for KALBITOR® (ecallantide) sales well into 2011.

General and administrative expenses for the fourth quarter of 2009 were $6.9 million, as compared to $7.0 million for the comparable quarter in 2008. For the year ended December 31, 2009, general and administrative costs increased to $25.8 million, as compared to $22.7 million for the 2008 year. The higher general and administrative costs in 2009 were primarily due to increased infrastructure to support plans for commercialization of KALBITOR, a treatment for acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older, which was recently made commercially available in the United States.

For the quarter ended December 31, 2009, Dyax reported a net loss of $10.9 million or $0.14 per share, as compared to a net income of $6.4 million or $0.10 per share for the comparable quarter in 2008. Net income in the 2008 quarter was due to the timing of recognition of previously deferred revenue from license and collaboration agreements entered into during 2008. For the year ended December 31, 2009, the net loss was $62.4 million or $0.90 per share, as compared to $66.5 million or $1.08 per share for the 2008 year.

As of December 31, 2009, Dyax had cash, cash equivalents, and investments totaling $52.4 million, exclusive of restricted cash.

Corporate Progress and Guidance

“The year ended with a landmark accomplishment for Dyax, the approval of our first product, KALBITOR, which was discovered and developed by Dyax. The recent market launch of KALBITOR transitions our company into a new and exciting stage – a fully integrated biopharmaceutical organization,” stated Gustav Christensen, President and Chief Executive Officer of Dyax. “We are now focused on ensuring its commercial success, while continuing to advance the other research and development activities that support Dyax as a fully integrated company.”

Continued, Mr. Christensen, “Looking ahead into 2010, we anticipate reporting on several achievements including: progress with the launch of KALBITOR; finalizing one or more ex-North America partnerships for addressing its commercial success abroad; advancements with DX-88 clinical programs for other indications; and completing additional strategic partnerships under our Licensing and Funded Research Program. Our exciting achievement of recent regulatory and commercial milestones was made possible because of the dedication of our employees and the commitment from our shareholders and the HAE network of patients and physicians. We look forward to building upon this momentum over the next year.”

2010 Guidance

George Migausky, Executive Vice President and Chief Financial Officer of Dyax, stated, “The financial results of 2009 demonstrate how we have effectively managed costs while concurrently building the commercial infrastructure for the U.S. launch of KALBITOR. Where appropriate, we have strengthened the balance sheet in order to have available the financial resources to carry out our business plan. At this time, we believe we have the cash and resources to support ongoing operations into 2011.”

Webcast and Conference Call

Dyax Corp. will host a webcast and conference call, including an open question and answer session.

Date: Wednesday, February 17, 2010
Time: 10:00 a.m. ET
Telephone Access: Domestic callers, dial 866-804-6921
International callers, dial 857-350-1667
Passcode 12327245
Online Access: Go to the Investor Relations section of the Dyax website (www.dyax.com) and follow instructions for accessing the live webcast. Participants may register in advance.


A replay of the conference call will be available through March 17, 2010 and may be accessed by dialing 888

[surf1944]

KALBITOR® (ecallantide) Now Commercially Available
- KALBITOR Orders Being Coordinated Through KALBITOR AccessSM -
- Call 1-888-452-5248 or Visit www.KALBITOR.com for Information -

Companies:Dyax Corp.
HAE patient before and during an acute hereditary angioedema (HAE) attack. HAE attacks can occur in the abdomen, face, hands, feet and airway. This photo shows an example of a facial attack. (Photo: Dyax Corp.).  <a href='http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6163519'>View Multimedia Gallery</a>

Press Release Source: Dyax Corp. On Tuesday February 2, 2010, 7:30 am EST
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ:DYAX) announced today that KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older is now commercially available in the United States.

HAE is a rare, genetic disorder characterized by severe, debilitating and often painful swelling, which can occur in the abdomen, face, hands, feet and airway. KALBITOR, a potent, selective and reversible plasma kallikrein inhibitor discovered and developed by Dyax, is the first subcutaneous HAE treatment approved in the U.S.

Orders for KALBITOR will be coordinated through KALBITOR AccessSM. The KALBITOR Access team of dedicated insurance specialists and nurse case managers will provide patients, caregivers and physicians product information, help with treatment site coordination, assist with verifying insurance coverage and reimbursement, and will process KALBITOR orders from physicians and healthcare facilities.

As part of product approval, Dyax has implemented a Risk Evaluation and Mitigation Strategy (REMS) program, consisting of a Medication Guide and Communication Plan. The goal of the REMS is to communicate the risk of anaphylaxis and the importance of distinguishing between a hypersensitivity reaction and HAE attack symptoms.

“Our launch strategy was developed with a very important goal in mind: to ensure that patients and physicians throughout the U.S. have access not only to KALBITOR, but also to our customized patient support services and comprehensive product and disease information,” said Gustav A. Christensen, President and Chief Executive Officer of Dyax.

In addition to identifying an exclusive specialty pharmacy to manage the distribution and inventory of KALBITOR through KALBITOR Access, Dyax has built a focused, field-based commercial infrastructure consisting of commercial sales professionals, medical sales liaisons and payer corporate account directors with a breadth of experience in launching specialty biologics. At the same time, Dyax has been concentrating on building awareness about this still misdiagnosed condition which was recently highlighted by the launch of HAE Hope (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.haehope.com%2F&esheet=6163519&lan=en_US&anchor=www.HAEHope.com&index=7&md5=00025b56de28924187143665706eb9d8), an online resource to help patients and their families better understand and manage HAE.

“With the availability of KALBITOR for my acute attacks and the support services provided, my hope to manage my unpredictable acute attacks may now be closer to a reality,” said Joan Angert, who was only officially diagnosed with HAE 3 years ago. “Because of HAE, I have been limited in my work and personal life, and because the swelling attacks frequently occur in my throat, I live in a constant state of fear.”

“Characteristics such as not being derived from human-plasma and having a subcutaneous route of administration and well demonstrated efficacy in treating acute attacks in patients 16 years of age and older, regardless of anatomic location, are factors that should make KALBITOR an important treatment option for any physician treating patients with HAE,” said Dr. William E. Lumry, Medical Director of the Asthma, Allergy Research Associates (AARA) Research Center in Dallas, TX.

KALBITOR AccessSM

Patients and healthcare providers can contact KALBITOR AccessSM to receive information and work with program staff to research patient insurance coverage for KALBITOR. KALBITOR Access is designed as a one-stop point of contact for information about KALBITOR. The program is staffed with dedicated insurance specialists and nurse case managers who will help coordinate patient treatment and access to KALBITOR. Patients and healthcare providers can call 1-888-4KALBITOR (1-888-452-5248) for information and to utilize these services or visit www.KALBITOR.com.

KALBITOR HAE Program

The approval of KALBITOR is based on the results of two placebo-controlled Phase 3 clinical studies, known as EDEMA3® and EDEMA4®. Patients having an attack of HAE, at any anatomic location, with at least one moderate or severe symptom, were treated with 30 mg subcutaneous KALBITOR or placebo. Because patients could participate in both trials, a total of 143 unique patients participated. There were 64 patients with abdominal attacks, 55 with peripheral attacks, and 24 with laryngeal attacks. In both trials, the effects of KALBITOR were evaluated using the Mean Symptom Complex Severity (MSCS) score and the Treatment Outcome Score (TOS), two HAE-specific patient-reported outcome endpoints developed by Dyax. These measures evaluated the severity of attack symptoms at all anatomical locations (MSCS score) and response to therapy (TOS). In the EDEMA4 trial at 4 hours, patients treated with KALBITOR demonstrated a greater decrease from baseline in the mean MSCS than placebo (-0.8 vs. -0.4; p = 0.010) and a greater mean TOS (53 vs. 8, p = 0.003). In the EDEMA4 trial at 24 hours, patients treated with KALBITOR also demonstrated a greater decrease from baseline in the mean MSCS than placebo (-1.5 vs. -1.1; p = 0.04) and a greater mean TOS (89 vs. 55, p = 0.03). The results in the EDEMA3 trial were consistent with the EDEMA4 trial results.

Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR. In 255 HAE patients treated with intravenous or subcutaneous KALBITOR in clinical studies, 10 patients (3.9%) experienced anaphylaxis. For the subgroup of 187 patients treated with subcutaneous KALBITOR, 5 patients (2.7%) experienced anaphylaxis. Symptoms associated with these reactions have included chest discomfort, flushing, pharyngeal edema, pruritus, rhinorrhea, sneezing, nasal congestion, throat irritation, urticaria, wheezing, and hypotension. These reactions occurred within the first hour after dosing.

The most common adverse reactions occurring in =3% of KALBITOR-treated patients and greater than placebo were headache, nausea, diarrhea, pyrexia, injection site reactions, and nasopharyngitis.

Important KALBITOR Safety Information

Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. KALBITOR should not be administered to patients with known clinical hypersensitivity to KALBITOR.

For more information about KALBITOR, including full prescribing information, visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.KALBITOR.com&esheet=6163519&lan=en_US&anchor=www.KALBITOR.com&index=10&md5=1d50b

[surf1944]

Dyax Launches HAE Hope, A New Online Resource for Patients with Hereditary Angioedema
Website Offers Tools for Recognizing Attack Triggers and Managing the Disease

Press Release Source: Dyax Corp. On Thursday January 14, 2010, 7:30 am EST
CAMBRIDGE, Mass.--(BUSINESS WIRE)--A new, online resource is now available for patients with hereditary angioedema (HAE), their caregivers and physicians. The website, www.HAEHope.com, launched today by Dyax Corp. (NASDAQ: DYAX), offers resources to help patients and their families better understand and manage HAE, a rare, genetic disease characterized by episodes of severe and painful swelling.

A number of features of HAE Hope are designed to help patients with HAE to better understand and manage the disease. These include, an “Ask the Expert” feature offering responses from an HAE treating physician, key questions to facilitate a discussion with a healthcare professional, and a personalized wallet card identifying a patient as someone with HAE and describing typical disease symptoms to use in case of an emergency. Another unique feature of HAE Hope is a 3-D animation that provides an overview of the physiological processes associated with HAE.

“HAE Hope provides valuable information that can better equip patients to gain more control over their disease and handle the challenging situations they confront regularly,” says Greg Costa, who was diagnosed with HAE more than 20 years ago at the age of 19. “As a father of two, I also understand how important it is to have resources like HAE Hope available for patients’ family members to teach them about this debilitating disease and how to manage potential emergencies with their loved one.”

HAE is a rare, genetic disease caused by low or dysfunctional levels of C1 esterase inhibitor, a naturally occurring molecule that inhibits plasma kallikrein, a key mediator of inflammation. The condition is “hereditary” because it is caused by a genetic deficiency that is passed down in families. When a parent has HAE, there is a 50% chance that his or her child will inherit the disease, which can help with an earlier diagnosis. However, in as many as 25% of patients, the gene mutates on its own. Consequently, many patients are unaware they have HAE and may receive a delayed diagnosis.

“Even when HAE is inherited, it is often unrecognized or misdiagnosed because it is rare and its symptoms are similar to those of many other conditions. Historically, the interval between the onset of symptoms and diagnosis has been as long as 10 to 20 years,” explained Dr. Andrew J. MacGinnitie, HAE treating physician and allergist/immunologist at the Children’s Hospital of Pittsburgh of UPMC. “The information and tools provided on HAE Hope may help more patients receive an accurate diagnosis, and better understand their symptoms and how to manage them.”

In addition to the tools described above, HAE Hope offers several other user-friendly features, including:


•A “Do I Have HAE” questionnaire designed to help patients track their symptoms to facilitate a discussion with their healthcare provider if they are experiencing possible indicators of HAE
•Helpful tips from HAE patients on topics ranging from managing attacks to parenting a child with HAE
•Links to other online resources to learn more about HAE, including the U.S. Hereditary Angioedema Association

[surf1944]

Merck buys British maker of biotech medicines
Merck expands push into biotech drugs with purchase of Avecia, British contract manufacturer

By Linda A. Johnson, AP Business Writer , On Thursday December 17, 2009, 1:32 pm EST
TRENTON, N.J. (AP) -- Merck & Co. said Thursday it is making another deal in its strategy to become a top maker of biotech drugs, buying a British company that makes them.

Merck, the world's second-biggest drugmaker, said its United Kingdom subsidiary, Merck Sharp & Dohme Ltd., has agreed to acquire Avecia Biologics from its parent holding company.

Specific financial terms of the deal were not disclosed, but Merck spokesman Ian McConnell said the value is well below $1 billion.

Avecia has been making small amounts of biotech drugs for use in patient tests of experimental treatments for heart disease, blood disorders and cancers for a number of companies since 1998. The drugs are "manufactured" in fermentation tanks containing rapidly reproducing cells including yeast and E. coli, with the active molecule then separated out and purified to produce medication.

The company, which is based in Billingham, U.K., and employs 500 people, is making a drug for commercial sale for the first time, for client Dyax Corp. Avecia spokeswoman Bridget Hall said that drug, soon to be launched under the brand name Kalbitor, is for swelling in the extremities.

Biologics, or biotech drugs, are grown in mammal, yeast or other cells rather than chemically synthesized like traditional pills. They are one of three areas that Merck, based in Whitehouse Station, N.J., is targeting for growth.

"This is one component of our increasing our resources and capabilities in biologics," McConnell said of the deal.

Last December, Merck launched a new division called Merck BioVentures to make both new and follow-on, or generic, biotech drugs. They are starting to arrive in Europe, but are not yet allowed in the U.S. -- although proposals to establish rules allowing them have been a hot part of the health care overhaul debate.

Company executives have said the unit will invest $1.5 billion in research by 2015 and aim to launch six or more generic biotech products from 2012 through 2017, a period when some major biotech drugs lose patent protection.

In February, Merck said it was buying a manufacturing facility and a group of potential generic biotech drugs, for preventing infections in cancer patients, from Insmed Inc. for $130 million.

Merck also gained Schering-Plough Corp.'s biotech operations when it acquired that company in November for $41.1 billion. Right after that deal closed, Merck Chief Executive Richard Clark said the company plans to make deals with biotech companies with first or best-in-class products, and has about $8 billion to spend.

Merck shares fell 30 cents to $37.45 in afternoon trading Thursday.

[surf1944]

Cubist's acquisition to add value

Companies:Cubist Pharmaceuticals Inc.Dyax Corp.Teva Pharmaceutical Industries Limited.Related

By Zacks equity Research , On Wednesday December 16, 2009, 11:45 am EST
Recently, Cubist Pharmaceuticals (NasdaqGS: CBST - News) decided to acquire a privately held biopharmaceutical company Calixa Therapeutics for an upfront payment of $92.5 million. Additionally, Cubist would be required to make a payment of another $310 million on the achievement of certain development, regulatory, and commercial milestones. Calixa is primarily focused on the development of antibiotics to treat serious bacterial infections. The deal is expected to close by year end.

Following the deal, Cubist will gain rights to Calixa’s lead compound CXA-201 (containing CXA-101), an intravenous treatment in mid-stage trial for the treatment of urinary tract and intra-abdominal infections caused by Pseudomonas aeruginosa. In addition, Cubist will also receive rights to another compound CXA-101 and any other drugs incorporating CXA-101, which was acquired from Astellas Pharma. Cubist plans to begin clinical studies of CXA-201 for the nosocomial pneumonia indication as well in the second half of 2010. Provided results are encouraging, Cubist expects to file a New Drug Application (NDA) for CXA-201 in the second half of 2013.

Cubist has sufficient funds to complete the acquisition as well as the development of Calixa’s product candidates. At the end of September 30, 2009, the company had $500 million in cash and short-term investments on its books. We believe the acquisition of Calixa will boost Cubist’s portfolio of antibiotics, which includes Cubicin (daptomycin for injection) to treat complicated skin infections and bacteremia caused by methicillin-resistant Staphylococcus aureus (MRSA) bacteria.

This is good news for Cubist especially after the recent setback it received for one of its pipeline candidates. Early this month, Cubist had to stop patient enrollment in trials of ecallantide, a drug intended to reduce bleeding during heart surgery because of deaths among patients that took the drug. The drug was licensed from Dyax Corporation (NasdaqGM: DYAX - News). Cubist is also facing a patent challenge from Teva pharmaceuticals (NasdaqGS: TEVA - News), which is developing a generic version of Cubicin. A trial date has been set for April 25, 2011.

[surf1944]

Dyax DYAX Wedbush Morgan changed to Outperform & price target from $9 to $7

[fazfas]

nice call on dyax.didn't buy,but thank you!

[Camaro1093]

Needham Lifts Price Target on Dyax (DYAX) to $8


* Needham Lifts Price Target on Dyax (DYAX) to $8
* Dyax (DYAX) Receives FDA Approval of KALBITOR(R) for Treatment of Acute Attacks of Hereditary Angioedema
* Dyax Announces FDA Approval of KALBITOR(R) (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema in Patients 16 Years of Age and Older
* DX-88 (ecallantide) Demonstrated Relief of Symptoms in Hereditary Angioedema Acute Attacks in All Attack Locations

December 2, 2009 9:56 AM EST

Needham & Co lifted theier price targete on Dyax Corp. (Nasdaq: DYAX) to $8 from $6, following FDA approval of KALBITOR for the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older. The firm's Buy rating was maintained.

Analyst Mark Monane states "We are encouraged by KALBITOR label for treatment in HAE regardless of anatomic location and note that KALBITOR represents the only approved treatment option for life-threatening laryngeal attacks. The Company is working on a pediatric development plan for KALBITOR with the EMEA, and while the US KALBITOR label did not include an indication in patients 12-15 years old, we expect off-label use in this population due to multiple similarities with adults, yet limited use in patients 9-12 years old. As we expected, KALBITOR use, although given SQ, is limited at this time to the ER or medical office area: future studies are planned to optimize use of KALBITOR in further outpatient or home settings."

Link:

http://www.streetinsider.com/Analyst+Comments/Needham+Lifts+Price+Target+on+Dyax+(DYAX)+to+%248/5152632.html

[Camaro1093]

We have pretty good volume. But it can't seem to break out of the $4.25-4.30 range...

GLTA.

[fink]

Who wants to buy today?

Looks like the MM think pretty high of this with this opening +$1.00

I see alot of profit taking today.

Volume is the key and looks good.
News @ EOD is always a rip off. Could you imagine the Gap down this would have had and the massive run into lunch and EOD today. Still looking good.
Been a fun ride!
GLTA

[Camaro1093]

Approved! And a sweet After Hours close @ 5.10

GLTA!

[surf1944]

5:54PM Dyax announces FDA approval of KALBITOR (ecallantide) for the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older (DYAX) 3.50 -0.23 : Co announced that the U.S. Food and Drug Administration (FDA) has granted approval for KALBITOR (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.

[mlkrborn]

GL2Utoo!

[Camaro1093]

I finally got filled @ 3.63...

GLTA!