Lilly and Investor Group Form New Critical Care Company BioCritica, Sign Xigris License Agreement

INDIANAPOLIS, May 23, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that it has signed agreements with private investors Care Capital and NovaQuest Capital to establish BioCritica Inc., a newly-formed and privately-held biotechnology company. BioCritica, based in Central Indiana, will initially focus on the continued U.S. development and commercialization of Xigris® (drotrecogin alfa (activated)), Lilly's medicine for severe sepsis. BioCritica intends to ultimately build a broad portfolio of innovative, hospital-based critical care medicines.

As part of a licensing agreement, BioCritica will acquire the U.S. development and commercialization rights to Xigris and will also receive the rights to potentially acquire several critical care compounds currently in pre-clinical development at Lilly. The collaboration also includes a supply agreement, a services agreement and an option for BioCritica to potentially acquire the development and commercialization rights to Xigris outside the U.S. at a later date. In return, Lilly will receive royalties on future U.S. sales of Xigris and will also receive an equity stake in BioCritica. Specific financial terms of the transaction are not being disclosed.

The creation of BioCritica received the support of the Indiana Economic Development Corporation (IEDC) and BioCrossroads, Indiana's public-private initiative to grow, advance and invest in the life sciences. BioCritica's formation and the Lilly-BioCritica collaboration are the latest successes in the state's efforts to attract new life sciences companies to Central Indiana.  

"We are pleased to announce the formation of a new life sciences company in Central Indiana, BioCritica. The collaboration between Lilly and BioCritica will benefit both companies, as well as the patients we serve and the Indianapolis community in which we operate," said John C. Lechleiter, Ph.D., Lilly president, chairman and chief executive officer. "We are confident that BioCritica will help realize the full potential for Xigris, while working to develop new critical care medicines. We look forward to working with BioCritica to help ensure its success."

"For severe sepsis patients, Xigris is an important life-saving drug," said David Broecker, chief executive officer of BioCritica.  "Each year more than 200,000 people die from severe sepsis in the U.S. We look forward to building a company dedicated to saving lives.  We also appreciate the support of Lilly, the IEDC, and BioCrossroads in helping us get established here in Indiana."

"Indiana's consistently strong growth in the life sciences sector is evidence that not only do we have the talent to power some of the world's top biotechnology companies, but we also have an environment welcoming to the kind of noticeable impact companies like BioCritica and others will have on our state's economy and the quality of life of citizens everywhere," said Mitch Roob, Indiana Secretary of Commerce and chief executive officer of the Indiana Economic Development Corporation.  

IMPORTANT SAFETY INFORMATION

About Xigris® (drotrecogin alfa (activated))

Injection, Powder, Lyophilized, For Solution for Intravenous

5 mg and 20 mg vials

Indications:

Xigris is indicated for the reduction of mortality in adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death (e.g., as determined by APACHE II score greater than or equal to 25*).

Limitations of Use:

Xigris is not indicated in adult patients with severe sepsis and lower risk of death. (e.g., APACHE II score <25).

Xigris is not indicated in pediatric patients.  

CONTRAINDICATIONS

Xigris increases the risk of bleeding. Xigris is contraindicated in the following clinical situations where bleeding could lead to significant morbidity or death:

• Active internal bleeding
• Recent (within 3 months) hemorrhagic stroke
• Recent (within 2 months) intracranial or intraspinal surgery, or severe head trauma
• Trauma with an increased risk of life-threatening bleeding
• Presence of an epidural catheter
• Intracranial neoplasm or mass lesion or evidence of cerebral herniation

WARNINGS and PRECAUTIONS

Bleeding is the most common serious adverse effect associated with Xigris therapy. Each patient being considered for therapy with Xigris should be carefully evaluated and anticipated benefits weighed against potential risks associated with therapy.

Certain conditions, many of which led to exclusion from the Phase 3 clinical trial (PROWESS), are likely to increase the risk of bleeding with Xigris therapy. Therefore, for patients with severe sepsis who have one or more of the following conditions, the increased risk of bleeding should be carefully considered when deciding whether to use Xigris therapy:

• Concurrent therapeutic dosing of heparin to treat an active thrombotic or embolic event
• Platelet count <30,000 x 10,000,000/L, even if the platelet count is increased after transfusions
• Prothrombin time-INR >3.0
• Recent (within 6 weeks) gastrointestinal bleeding
• Recent administration (within 3 days) of thrombolytic therapy
• Recent administration (within 7 days) of oral anticoagulants or glycoprotein IIb/IIIa inhibitors
• Recent administration (within 7 days) of aspirin >650 mg per day or other platelet inhibitors
• Recent (within 3 months) ischemic stroke
• Intracranial arteriovenous malformation or aneurysm
• Known bleeding diathesis
• Chronic severe hepatic disease
• Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location

Should clinically important bleeding occur, immediately stop the infusion of Xigris. Continued use of other agents affecting the coagulation system should be carefully assessed. Once adequate hemostasis has been achieved, continued use of Xigris may be reconsidered.

• Mortality In Patients with Single Organ Dysfunction and Recent Surgery  

Among the small number of patients in PROWESS, with single organ dysfunction and recent surgery (surgery within 30 days prior to study treatment), all-cause mortality was numerically higher in the Xigris group (28day: 10/49; inhospital: 14/48) compared with the placebo group (28day: 8/49; inhospital: 8/47).

In an analysis of the subset of patients with single organ dysfunction and recent surgery from the ADDRESS study, which enrolled septic patients not at high risk of death, allcause mortality was also higher in the Xigris group (28day: 67/323; inhospital: 76/325) compared with the placebo group (28day: 44/313; inhospital: 62/314). Single organ dysfunction patients with recent surgery may not be at high risk of death irrespective of APACHE II score. Therefore, these patients may not be among the indicated population.

• Patients on Prophylactic Heparin when Xigris is Initiated

Clinicians should consider continuing heparin for venous thromboembolism (VTE) prophylaxis when initiating Xigris, unless discontinuation is medically necessary. In a randomized study of prophylactic heparin versus placebo in 1935 adult severe sepsis patients treated with Xigris, mortality and the rate of serious adverse events were increased in the subgroup of 434 patients whose heparin was stopped on study entry by randomization to placeboplusXigris. This finding was based on prospectively defined exploratory subgroup analyses; however, the explanation for the finding is unclear. The safety of prophylactic heparin when concomitantly administered with Xigris in adult patients with severe sepsis was evaluated with low molecular weight heparin enoxaparin (40 mg every 24 hours) and unfractionated sodium heparin (5000 U every 12 hours), but was not evaluated with unfractionated sodium heparin 5000 U when dosed every 8 hours.

• Invasive Procedures

Invasive procedures increase the risk for bleeding with Xigris. Such procedures, including arterial and central venous punctures, should be minimized during the Xigris infusion. Puncture of a noncompressible site should be avoided during the infusion. Xigris should be discontinued 2 hours prior to undergoing an invasive surgical procedure or procedures with an inherent risk of bleeding. Once adequate hemostasis has been achieved, Xigris may be restarted 12 hours after surgery and major invasive procedures or immediately after uncomplicated less invasive procedures.

ADVERSE REACTIONS

Bleeding is the most commonly reported adverse reaction in patients receiving Xigris therapy. Patients administered Xigris as treatment for severe sepsis experience many events which are potential sequelae of severe sepsis and may or may not be attributable to Xigris therapy. In severe sepsis clinical trials, there were no types of nonbleeding adverse events suggesting a causal association with Xigris.

In the PROWESS study, serious bleeding events were observed during the 28-day study period in 3.5% of Xigris-treated and 2.0% of placebo-treated patients. The difference in serious bleeding occurred primarily during infusion.

The incidence of intracranial hemorrhage (ICH) during the study period was 0.2% for Xigristreated patients and 0.1% for placebotreated patients. ICH has been reported in patients receiving Xigris in nonplacebo controlled trials with an incidence of approximately 1% during the infusion period. The risk of ICH may be increased in patients with risk factors for bleeding such as severe coagulopathy and severe thrombocytopenia.

*APACHE (Acute Physiology And Chronic Health Evaluation).

Please refer to the full Prescribing Information for Xigris

About BioCritica

BioCritica is a biotechnology company focused on meeting the critical care needs of patients and clinicians in the hospital market.  In addition to Xigris for the treatment of severe sepsis, BioCritica is developing a pipeline of other products.  Our mission is to develop and commercialize products that make a dramatic improvement in people's lives. www.biocritica.com

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs.  Additional information about Lilly is available at www.lilly.com.  C-LLY

About IEDC

Created by Governor Mitch Daniels in 2005 to replace the former Department of Commerce, the Indiana Economic Development Corporation is governed by a 12-member board chaired by Governor Daniels. Mitch Roob serves as the chief executive officer of the IEDC.  For more information about IEDC, visit www.iedc.in.gov.

About Care Capital

Care Capital is a life sciences venture capital firm based in Princeton, New Jersey. It manages approximately $500 million in capital and invests in entrepreneurial biotechnology and specialty pharmaceutical companies that are developing pharmaceutical assets across all therapeutic areas. For more information, please visit www.carecapital.com.

About NovaQuest

NovaQuest manages private equity and other investments in the global biopharmaceutical sector, where its principal focus is investing in late-stage clinical assets and commercial phase biopharmaceutical products. Over the past decade, the team has worked together to invest approximately $882 million. For more information, please visit www.nqcapital.com.

This press release contains forward-looking statements about the benefits of a collaboration between Lilly and BioCritica and the potential of BioCritica's future product pipeline. It reflects Lilly's and BioCritica's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of implementing the transaction and in drug development.  There is no guarantee Lilly or BioCritica will realize the expected benefits of the transaction, or that BioCritica will develop a pipeline that will yield commercially successful products.  For further discussion of these and other risks and uncertainties, please see Lilly's latest Form 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. The companies undertake no duty to update forward-looking statements.

Xigris® (drotrecogin alfa (activated)), Lilly

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SOURCE Eli Lilly and Company