Linjeta (prandial insulin) / Ipsen - LARVOL DELTA

Biodel Reports Fourth Quarter and Fiscal Year 2010 Financial Results (PRNewswire) -

Biodel reported a net loss for Q4 ’10 of $8.1M vs. a net loss of $10.5M for Q4 ’09; In fiscal year 2011, Biodel intends to conduct preclinical studies and P1 clinical trials to determine whether its newer insulin formulations are likely to offer a combination of pharmacokinetic, stability and tolerability characteristics that is preferable to Linjeta;

Pipeline update

Biodel to raise $30 million through registered direct offering (PRNewswire) - Biodel entered into definitive agreements with a group of institutional investors, including Great Point and Orbimed to sell 12.2M shares of its common stock, 1.7M shares of its series A convertible preferred stock and warrants to purchase 9.0M shares of its common stock

Agreement • Diabetes

Biodel to report second quarter fiscal year 2011 financial results on May 5, 2011 (PRNewswire) - Biodel to report Q2 ‘11 financial results & host a conference call on May 05 ’11

Diabetes

Biodel Inc. to Present at 29th Annual JPMorgan Healthcare Conference on January 13th, 2011 (PRNewswire) -

Biodel to present a corporate update at the 29^th Annual JPMorgan Healthcare Conference on Jan 13 ’11;

Anticipated presentation • Diabetes

Linjeta - FDA's top 10 blockbuster decisions (FierceBiotech) - Biodel had a hard time lining up a major partner to market Linjeta, a sign of worries that Biodel will gain a complete response letter outlining some expensive and extensive new work on the therapy;

Diabetes

Modified Linjet formulations reduce local injection site discomfort while maintaining ultra-rapid insulin absorption profiles (ADA 2011) - Publish only abstract; P=NA, N=67; VJ25 & VJ7 resulted in VAS scores of 22.0± 2.8 & 17.3 ±2.5 (p=0.041 for difference between Linjeta formulations), respectively, compared to a score of 5.3 ±1.0 for insulin lispro; In second study (n=13) BIOD-102 & -103 received VAS scores of 4.0 ±1.2 & 9.0 ±2.6 respectively compared to a score of 20.6 ±6.7 for VJ7 (p=0.028 & 0.112 for difference between BIOD-102 & -103 respectively & VJ7)

Clinical data • Diabetes

Biodel Rises Most Ever on Optimism of Deal Related to Experimental Insulin (Bloomberg.com) -

Biodel rose the most since it began selling public shares in May 2007 on an analyst’s note expressing optimism about the company’s insulin product;

Financial update • Diabetes

Assessment of long-term safety and efficacy of Linjeta™ with 18 months of continuous therapy in patients with type 1 diabetes (ADA 2011) - P=NA, N=223; A1C, hypoglycemic event rates, weight and insulin antibody levels showed only minor variations over the 18 month period of observation; Local injection site adverse events declined with time; Eight subjects withdrew from the study due to injection site reactions; No correlations were identified between insulin antibody levels and measures of glycemic control

Diabetes

JMP Securities Healthcare Conference (Biodel) - Anticipated US patent expiry in January 2026; Anticipated EU patent expiry in March 2025

Anticipated patent expiry • Diabetes

Assessment of long-term safety and efficacy of Linjeta™ with 18 months of continuous therapy in patients with type 2 diabetes (ADA 2011) - Presentation time: June 25, 2011: 11:30 AM - 1:30 PM; P=NA, N=284; A1C, hypoglycemic event rates, weight and insulin antibody levels showed only minor variations over the 18 month period of observation; A1C(%), Hypoglycemia(events/subject-month)Weight(kg), Prandial Dose(U/day), Basal Dose(U/day), Insulin Antibody Levels(U/ml) were 7.62 [plusmn] 1.16(161), 1.59(183), 93.3 [plusmn] 23.2(162), 37.5 [plusmn] 24.7(183), 53.7 [plusmn] 40.6(183), 2.7 [plusmn] 3.9(159)

Clinical data • Diabetes