LB Pharmaceuticals Inc · NASDAQ:LBRX
LB Pharmaceuticals — Technical Presentation (October 2017)
13 slides from LB Pharmaceuticals's technical presentation, October 2017
Slide 1: Additional Due Diligence Materials: IP Overview, October 2017
A D D I T I O N A L D U E D I L I G E N C E M AT E R I A L S IP OVERVIEW OCTOBER 2017
Slide 2: Overview of Intellectual Property
OVERVIEW OF INTELLECTUAL PROPERTY • We are developing LB-102 and LB-103: novel derivatives of amisulpride with the addition of a methyl group • Provisional patent application (62/427062) filed November 2016 and amended May 2017 (62/508263), covers composition of matter. • LB will file PCT applicatio
Slide 3: Patentability of LB-102 and LB-103
PATENTABILITY OF LB-102 AND LB-103 • US Federal Court (Proctor & Gamble v Teva, 566 F.3d 989, 996) affirms that a presumption of obviousness is overcome when there is no reasonable expectation of similar properties • A priori there is no way to know if addition of a single methyl group to amisulprid
Slide 4: Patented Methylated Antipsychotic
PATENTED METHYLATED ANTIPSYCHOTIC Desvenlafaxine (PFE, Pristiq), US Patent 4,535,186, COM as HCl salt, filed 10/26/83 by AHP. Succinate, US Patent 6,673,838, filed 2/11/02 by WYE Paragraph IV (P IV) challenge filed in 2012 (litigation was not related to COM claims), generic launched in March 2017 Ve
Slide 5: Patented Hydroxylated Antipsychotic
PATENTED HYDROXYLATED ANTIPSYCHOTIC Risperidone (JNJ, Risperdal), US Patent 4,804,663 COM, filed 2/5/86 by Janssen Apotex filed P IV in 2006 and lost on appeal in 2008 Paliperidone (JNJ, Invega), US Patent 5,168,952 COM, with a priority date of 11/7/88 by Janssen. Subsequent claims and pediatric exc
Slide 6: Patented Desmethylated Antipsychotic
PATENTED DESMETHYLATED ANTIPSYCHOTIC Clozapine (HLS, Clozaril), US Patent 3,539,573 COM, filed 10/21/68 by Jean Schmutz Generics launched in December 1997 ACP-104 (ACAD, Desmethylclozapine), US Patent 7,491,715 COM, filed 5/3/06 by ACAD (cip of 10/761,787, filed 1/21/04) Failed clinically but patent
Slide 7: GILD/MRK (VRUS/IDIX) Example
GILD/MRK (VRUS/IDIX) EXAMPLE IDIX (US Patent 7,608,597, filed 6/20/03) claimed all methyl halogen versions of the C-2’ modified uridine to treat HCV, but only reduced to practice claims for the Cl, Br, and I versions VRUS (US Patent 7,429,572, filed 4/21/04) claimed and enabled the fluorine halogen
Slide 8: Enantiomers Are Patentable
ENANTIOMERS ARE PATENTABLE Citalopram (FRX, Celexa), US Patent 4,136,193 COM, filed 1/7/77 by Kefalas Escitalopram (FRX, lexapro), US Patent 4,943,590 COM, filed 6/8/89 by Lundbeck FRX’ patent was upheld in a 2006 case against Teva. Generic approved in March 2012 LB PHARMACEUTICALS - CONFIDENTIAL 8
Slide 9: Deuterated Analogs Are Patentable
DEUTERATED ANALOGS ARE PATENTABLE Ivacaftor (VRTX, Kalydeco), US Patent 7,495,103 COM, filed 6/24/04 by VRTX CTP-656 (CNCE), US Patent Application 053323 COM, filed 9/23/16 by CNCE VRTX acquired rights in March 2017 for $160 million upfront and up to $90 million in milestones. CNCE had begun a P2 st
Slide 10: Alkermes N-Methyl Amisulpride
ALKERMES N-METHYL AMISULPRIDE • ALKS has filed 2 patent applications (14/702,967, filed 12/23/10, & 13/335,405, filed 12/22/11) to allow multiple loading of a polymer for sustained release • No efficacy data have been reported publicly • The USPTO issued a final rejection to the first application on
Slide 11: Acacia Pharmaceuticals
ACACIA PHARMACEUTICALS • Acacia is developing an injectable form of amisulpride (Baremsis/ADP421) for treatment of post operative nausea & vomiting • A 2/13/17 PR claimed that the company aimed to submit an NDA in the first half of 2017 • As of 7/24/17 no PR of such a filing has been released • Acac
Slide 12: Projected IND Enabling Study Timeline
PROJECTED IND ENABLING STUDY TIMELINE IND Opener enables Phase 2A POC. DDI studies help with inclusion/exclusion criteria and allow to determine if LB-102 is comparable to amisulpride in DDI potential. IND could be filed on month 12 after study initiation (does not take into account contractual time
Slide 13: Projected Timeline to Approval
PROJECTED TIMELINE TO APPROVAL Study No. Description Duration Q119 Q219 Q319 Q419 Q120 Q220 Q320 Q420 Q121 Q221 Q321 Q421 Q122 Q222 Q322 Q422 Q123 Q223 Q323 Q423 Q124 Q224 Q324 Q424 Q125 Q225 Q325 Q425 Q126 LB-102-101 Phase 1, n = 40, SAD 2 weeks LB-102-102 Phase 1, n = 40 MAD 2 weeks LB-102-201 Pha
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