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Actionable news in DYAX: Dyax Corp.,


The following excerpt is from the company's SEC filing.

Lead pipeline product, DX-2930, is a Phase 3-ready asset, offering

potentially transformative prophylactic therapy for HAE

DX-2930 has potential to expand HAE-treated patients and achieve annual worldwide sales of up to $2 billion with exclusivity beyond 2030

DX-2930 is supported by proof-of-concept Phase 1B data, demonstrating a >90% reduction in HAE attacks compared to placebo in the 300mg/400mg arms in patients with

2 attacks in the 3 months prior to study entry

Acquisition furthers Shires strategy to become a leading global biotech

Dublin, Ireland; and Burlingto n, Mass. November 2, 2015

Shire plc (LSE: SHP, NASDAQ: SHPG) and Dyax Corp. (NASDAQ: DYAX) today announced that Shire will acquire Dyax for $37.30 in cash per Dyax share, for aggregate upfront consideration of approximately $5.9 billion. Dyax shareholders may receive additional value through a non-tradable contingent value right (CVR) that will pay $4.00 in cash per Dyax share upon approval of DX-2930 in HAE, representing a potential additional $646 million in aggregate contingent consideration.

Dyax is a publicly traded, Massachusetts-based biotechnology company primarily focused on the development of plasma kallikrein (pKal) inhibitors for the treatment of HAE, a debilitating and sometimes life-threatening rare genetic disease. Dyax has already successfully developed and commercialized KALBITOR, which is approved for HAE acute treatment in patients 12 years of age and older, and represented an early innovation in HAE treatment.

Dyaxs most advanced clinical program is DX-2930, a Phase 3-ready, fully humanized monoclonal antibody targeting pKal with proof-of-concept Phase 1B efficacy data. This data demonstrate a > 90% reduction in HAE attacks compared to placebo in the 300mg/400mg arms in patients with

2 attacks in the 3 months prior to study entry.

DX-2930 has received Fast Track, Breakthrough Therapy, and Orphan Drug designations by the FDA and has also received Orphan Drug status in the EU. It is expected to enter Phase 3 clinical trials by year-end 2015. If approved for the prevention of Type 1 and Type 2 HAE, DX-2930 could generate estimated annual global sales of up to $2.0 billion.

Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX

Transaction Highlights

Adds Dyaxs DX-2930, a Phase 3-ready, long-acting injectable monoclonal antibody for HAE prophylaxis, with the potential to lower rates of HAE attacks and significantly improve patient convenience based on clinical trial data reported to date

Offers patent protection and anticipated regulatory exclusivity beyond 2030

Adds to Shires best-in-class therapies addressing significant unmet patient need

Shire and Dyax Combination

Combines Dyaxs HAE commercial and research and development expertise with Shires HAE leadership and proven ability to advance rare disease assets through development to commercialization

Provides additional early-stage antibody pipeline programs for the treatment of autoimmune diseases, diabetic macular edema and thrombosis

Adds Dyaxs well-established proprietary phage display antibody generation technology to Shires rare diseases discovery capabilities, as well as partnering revenue associated with Dyaxs Licensing and Funded Research Portfolio (LFRP)

Expands and extends Shires industry-leading HAE portfolio (FIRAZYR and CINRYZE), advancing its leadership position in rare diseases and enhancing an already robust growth profile

Brings potential for substantial value creation to Shires shareholders, with significant earnings accretion expected assuming FDA approval and anticipated DX-2930 launch in 2018

Furthers Shires transformation to a leading global biotech and world leader in rare diseases

Shire Chief Executive Officer Flemming Ornskov, M.D., commented:

This highly complementary transaction aligns with and accelerates our strategy to build a global leading biotechnology company focused on rare diseases and specialty conditions. It adds to our portfolio of best-in-class therapies addressing unmet needs in our core therapeutic areas, expanding and extending our leadership position in HAE. We have closely followed DX-2930s progress in the evolving HAE landscape for some time, and we admire the work of the Dyax team in moving this next-generation therapy forward. Through compelling proof of concept clinical data, this potentially transformative therapy has been shown to be both highly efficacious and convenient, two key product attributes desired by both physicians and patients.

Dr. Ornskov continued, DX-2930 is a strategic fit within our HAE domain expertise, and we are well-positioned to advance the development, registration, and commercialization of DX-2930 for the benefit of HAE patients. This transaction also offers other potential upside opportunities, including Dyaxs early-stage pipeline. Following the close of this transaction, we look forward to welcoming Dyax employees, who will bring to Shire substantial clinical and commercial expertise in HAE. Dyax is to be commended for the world class organization they have built focused on HAE.

I am also confident that our M&A expertise and the ongoing strength of our business will enable rapid and effective integration following the closing, as demonstrated by the success of our NPS and ViroPharma acquisitions. Even with this transaction, we will continue to have the financial firepower to pursue other value-added strategic acquisitions, including Baxalta.

Dyax President and Chief Executive Officer Gustav A. Christensen said:

We believe this transaction will deliver substantial value to our shareholders and highlights our shared commitment to bringing innovative medicines to patients who suffer from the devastating effects of HAE. Our approved product, KALBITOR, was an important first step to bringing a range of HAE medicines to patients. Shires expertise and proven rare disease patient identification and management capabilities make it the ideal partner to efficiently bring DX-2930 to HAE patients worldwide. Im proud of the company that our team has built, and Im confident that Dyaxs important mission and focus on improving the lives of patients will continue as part of the Shire family.

About HAE

HAE is a rare, debilitating genetic inflammatory condition, which causes episodes of swelling in the face, extremities, and GI tract and can be life threatening. It is estimated that 30-40% of patients afflicted by HAE in the U.S. and EU remain undiagnosed, creating a significant growth opportunity in this area. Further, prophylactic treatment is likely underutilized with roughly 40% of patients only treating their attacks acutely on an as-needed basis.

Information on DX-2930

Through the transaction, Shire will acquire DX-2930, a Phase 3-ready novel long-acting highly potent human monoclonal antibody inhibitor of pKal, which has patent protection and anticipated regulatory exclusivity beyond 2030. Proof of concept was demonstrated in a multi-center, randomized, double-blind, placebo-controlled, multiple ascending dose Phase 1B study in HAE patients, based on patients in 300mg, 400mg and placebo groups, who reported having at least two HAE attacks in the three months prior to study entry. Each patient received two treatments of DX-2930 separated by 14 days. During the pre-specified, primary efficacy interval of six weeks (Day 8 to 50), the HAE attack rate was reduced by over 90% in the DX-2930 combined 300mg and 400mg arms, with 0 attacks in the 300mg group (n=4; p < 0.0001) and 0.045 attacks per week in the 400 mg group (n=11; p =0.005), compared to 0.37 attacks per week in the placebo group (n=11). DX-2930 was well tolerated at all dose levels with no evidence of dose-limiting toxicity up to 400 mg. The most common adverse events were HAE attacks, injection site pain, and headache, which were not appreciably higher in the DX-2930 arms compared with placebo. In the study, a total of 37 patients were randomized to active drug or placebo in a 2:1 ratio across 4 dosing groups of 30, 100, 300, or 400mg. Each patient received two doses of DX-2930 or placebo, separated by 14 days, and was followed for 15 weeks after the second dose.

A post hoc analysis of a subgroup of four patients who participated in the Phase 1B study from the 300mg (1) and 400mg (3) cohorts with severe HAE (9-36 attacks in the prior 3 months) had no breakthrough attacks on DX-2930 during the observation period (Day 8 to 50).

There were no deaths or patient discontinuations due to an...